Testosterone for Treating Cachexia in Patients With Squamous Cell Carcinoma
Sponsor
The University of Texas Medical Branch, Galveston (Other)
Overall Status
Completed
CT.gov ID
NCT00878995
Collaborator
National Cancer Institute (NCI) (NIH)
28
1
2
71.9
0.4
Study Details
Study Description
Brief Summary
RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.
PURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
OBJECTIVES:
-
To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma.
-
To determine the testosterone therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma.
OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms.
-
Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo testosterone intramuscularly (IM) weekly for 7 weeks.
-
Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone IM weekly for 7 weeks.
Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires.
Blood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.
After completion of study treatment, patients are followed periodically for 1 year.
Study Design
Study Type:
Interventional
Actual Enrollment
:
28 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Nutrition and Anabolic Interventions in Squamous Cell Carcinoma
Actual Study Start Date
:
Jun 3, 2009
Actual Primary Completion Date
:
Jun 1, 2014
Actual Study Completion Date
:
Jun 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Standard of Care Therapy + Placebo Testosterone Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. |
Drug: Placebo Testosterone
Placebo (Saline) Testosterone given IM once per week.
|
| Active Comparator: Standard of Care Therapy + Testosterone Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks. |
Drug: Testosterone Enanthate 100 MG/ML
Testosterone Enanthate 100mg/ml given once per week IM.
|
Outcome Measures
Primary Outcome Measures
- Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. [7 weeks]
Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported.
Secondary Outcome Measures
- Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline [Baseline]
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed.
- Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks. [7 weeks]
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication.
- Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline. [Baseline]
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force.
- Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks [7 weeks]
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec.
- Body Weight as Measured by Scale at Baseline [Baseline]
Body weight in kilograms as measured by a scale at the baseline visit.
- Body Weight as Measured by Scale at 7 Weeks. [7 weeks]
Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication.
- Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline [Baseline]
Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
- Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks [7 weeks]
Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values.
- Physical Activity Levels as Measured by the ActiGraph Accelerometer [through study completion,up to 7 weeks]
Physical activity is reported as % time sedentary for the entire 7 week study.
- Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline [Baseline]
Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks [7 weeks]
Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline. [baseline]
Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks [7 weeks]
Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline. [Baseline]
Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline. [baseline]
Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline. [baseline]
Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline. [Baseline]
Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline. [baseline]
Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline. [Baseline]
Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline. [Baseline]
Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline. [baseline]
Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline. [Baseline]
Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline. [Baseline]
Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline. [baseline]
Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks. [7 weeks]
Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay.
- Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline [baseline]
Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit
- Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks [7 weeks]
Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit.
- Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline [baseline]
The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99.
- Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks [7 weeks]
The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99
- Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline [Baseline]
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
- Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks [7 weeks]
Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue.
- Mood Measured by Profile of Mood States at Baseline [baseline]
Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).
- Mood as Measured by Profile of Mood States at 7 Weeks [7 weeks]
Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best).
- Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline [Baseline]
Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).
- Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks [7 weeks]
Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life).
- 1-year Survival [1 year post study]
Number of participants who survived one year post study.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Diagnosis of advanced (stage IIB, IIIA, or IIIB) or recurrent squamous cell carcinoma
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Mini Mental State Examination score > 23
Exclusion Criteria:
-
Pregnancy
-
Evidence of hepatitis as indicated by a 3-fold increase in 2 out of 3 liver enzymes
-
Significant liver, renal, or heart disease
-
Diabetes mellitus or other untreated endocrine disease
-
Polycystic ovary syndrome and/or hyperthecosis
-
Androgen secreting tumors of the ovary and adrenal or any ovarian tumors (e.g., Sertoli- Leydig cell tumor)
-
Non-classical adrenal hyperplasia
-
Cushing's syndrome
-
Glucocorticoid resistance
-
Hyperprolactinoma or hypothyroidism
-
Lactose intolerance
-
Alcohol or drug abuse
-
Recent treatment (within 3 months) with anabolic steroids
-
Ongoing anticoagulant therapy
-
Any other circumstance that would preclude study participation, in the opinion of the principal investigator or study physician
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0361 |
Sponsors and Collaborators
- The University of Texas Medical Branch, Galveston
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Melinda Sheffield-Moore, PhD, University of Texas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00878995
Other Study ID Numbers:
- 06-073/10-207
- R01CA127971
- CDR0000629579
- GCRC#724/819
First Posted:
Apr 9, 2009
Last Update Posted:
Mar 12, 2018
Last Verified:
Mar 1, 2018
Keywords provided by The University of Texas Medical Branch, Galveston
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited via UTMB Oncology, Radiation Oncology, and ENT clinics by study physicians. |
|---|---|
| Pre-assignment Detail | Subjects began study before beginning chemotherapy and/or radiation therapy. 28 subjects enrolled total. 4 subjects withdrew before beginning the study. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Period Title: Baseline Study - Midpoint Study | ||
| STARTED | 12 | 12 |
| Baseline Study | 12 | 12 |
| COMPLETED | 12 | 10 |
| NOT COMPLETED | 0 | 2 |
| Period Title: Baseline Study - Midpoint Study | ||
| STARTED | 12 | 10 |
| COMPLETED | 12 | 10 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone | Total |
|---|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate | Total of all reporting groups |
| Overall Participants | 12 | 12 | 24 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
54
(7.97)
|
48.66
(12.26)
|
51.44
(10.30)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
41.7%
|
9
75%
|
14
58.3%
|
| Male |
7
58.3%
|
3
25%
|
10
41.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
16.7%
|
1
8.3%
|
3
12.5%
|
| Not Hispanic or Latino |
10
83.3%
|
11
91.7%
|
21
87.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
16.7%
|
2
16.7%
|
4
16.7%
|
| White |
10
83.3%
|
10
83.3%
|
20
83.3%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
12
100%
|
12
100%
|
24
100%
|
Outcome Measures
| Title | Change in Total Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry (DEXA) From Baseline to 7 Weeks. |
|---|---|
| Description | Total Lean Body Mass was measured on a GE Lunar iDEXA at baseline and 7 weeks. Percent change from baseline to 7 weeks is reported. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Reporting data for the 22 completing subjects only, since this data is reported as change over time. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 10 |
| Mean (Standard Deviation) [Percent change] |
-3.31
(6.34)
|
1.42
(7.25)
|
| Title | Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 at Baseline |
|---|---|
| Description | Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 9 |
| Mean (Standard Deviation) [Newton-Meters] |
81.77
(42.58)
|
122.50
(70.78)
|
| Title | Maximum Peak Isometric Leg Strength as Measured by Biodex Pro 4 at 7 Weeks. |
|---|---|
| Description | Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction. There was 1 set of 3 contractions at 100% force performed. This outcome was measured after 7 weeks of treatment with study medication. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 6 | 9 |
| Mean (Standard Deviation) [Newton-Meters] |
76.75
(25.22)
|
118.26
(62.26)
|
| Title | Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro 4 at Baseline. |
|---|---|
| Description | Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 24 subjects started the study but only 20 subjects were able to complete this outcome measure due to problems relating to their cancer. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 9 |
| Mean (Standard Deviation) [Watts] |
137.60
(86.77)
|
169.0
(99.71)
|
| Title | Maximum Peak Isokinetic Leg Extension as Measured by Biodex Pro 4 at 7 Weeks |
|---|---|
| Description | Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion set at a fixed speed of 120 degree/sec. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 15 subjects were able to complete this outcome measure at this time point due to problems related to their cancer. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 6 | 9 |
| Mean (Standard Deviation) [Watts] |
126.93
(57.05)
|
157.90
(84.49)
|
| Title | Body Weight as Measured by Scale at Baseline |
|---|---|
| Description | Body weight in kilograms as measured by a scale at the baseline visit. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 24 subjects began the study. Each subjects was able to complete this outcome measure at the baseline time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 12 |
| Mean (Standard Deviation) [Kilograms] |
65.98
(25.49)
|
63.11
(17.24)
|
| Title | Body Weight as Measured by Scale at 7 Weeks. |
|---|---|
| Description | Body Weight in kilograms as measured on a scale after 7 weeks of treatment with the study medication. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 22 subjects completed this outcome measure at the 7 week time point. 24 subjects started the study, 2 subjects dis-enrolled after the baseline visit. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 10 |
| Mean (Standard Deviation) [Kilograms] |
63.93
(24.79)
|
62.59
(17.83)
|
| Title | Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at Baseline |
|---|---|
| Description | Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 24 subjects completed this outcome measure at the baseline visit. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 12 |
| Mean (Standard Deviation) [kilo-calories per day] |
1329.20
(359.94)
|
1310.81
(398.16)
|
| Title | Energy Expenditure Reported as Kcal/Day as Measured by Indirect Calorimetry at 7 Weeks |
|---|---|
| Description | Energy expenditure and substrate oxidation as measured by indirect calorimetry using expired gases collected and analyzed for oxygen and carbon dioxide concentrations. 30 minutes of sampling was performed, the last 25 minutes were averaged to calculate mean Kcal/day values. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only 19 subjects were able to complete this outcome measure at this time point due to problems related to their cancer. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [kilo-calories per day] |
1338.10
(281.77)
|
1260.98
(222.32)
|
| Title | Physical Activity Levels as Measured by the ActiGraph Accelerometer |
|---|---|
| Description | Physical activity is reported as % time sedentary for the entire 7 week study. |
| Time Frame | through study completion,up to 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from only 12 subjects is presented due to a compliance issue with wearing the activity monitoring belts. A threshold was set to determine if subject was wearing the belt as directed. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 3 | 9 |
| Mean (Standard Deviation) [% time sedentary] |
73.55
(15.78)
|
74.74
(9.44)
|
| Title | Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at Baseline |
|---|---|
| Description | Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
67.02
(67.13)
|
260.69
(251.07)
|
| Title | Concentration of Cytokine Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) in Blood as Measured by Immunoassay at 7 Weeks |
|---|---|
| Description | Concentration of cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
64.15
(50.36)
|
191.17
(206.32)
|
| Title | Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
21.62
(15.61)
|
15.71
(7.89)
|
| Title | Concentration of Cytokine Interferon-gamma (IFN Gamma) in Blood as Measured by Immunoassay at 7 Weeks |
|---|---|
| Description | Concentration of cytokine Interferon-gamma (IFN gamma) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
20.63
(13.01)
|
11.66
(8.17)
|
| Title | Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.11
(1.95)
|
1.98
(0.60)
|
| Title | Concentration of Cytokine Interleukin 1 Beta (IL-1B) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 1 beta (IL-1B) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
2.13
(2.02)
|
1.71
(1.01)
|
| Title | Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.62
(2.87)
|
3.92
(2.33)
|
| Title | Concentration of Cytokine Interleukin 2 (IL-2) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 2 (IL-2) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.02
(2.67)
|
2.39
(1.43)
|
| Title | Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
4.30
(4.70)
|
3.13
(2.64)
|
| Title | Concentration of Cytokine Interleukin 4 (IL-4) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 4 (IL-4) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
10.48
(24.43)
|
2.35
(2.85)
|
| Title | Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.02
(2.22)
|
14.56
(26.29)
|
| Title | Concentration of Cytokine Interleukin 5 (IL-5) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 5 (IL-5) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.13
(1.98)
|
12.62
(24.71)
|
| Title | Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
11.04
(15.94)
|
43.99
(59.45)
|
| Title | Concentration of Cytokine Interleukin 6 (IL-6) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 6 (IL-6) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
8.89
(5.48)
|
23.09
(36.54)
|
| Title | Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
6.57
(2.49)
|
21.61
(36.35)
|
| Title | Concentration of Cytokine Interleukin 7 (IL-7) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 7 (IL-7) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
9.97
(7.35)
|
18.16
(25.88)
|
| Title | Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
14.57
(9.93)
|
16.62
(8.20)
|
| Title | Concentration of Cytokine Interleukin 8 (IL-8) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 8 (IL-8) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
11.45
(5.90)
|
12.34
(7.82)
|
| Title | Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
13.35
(13.99)
|
94.52
(200.92)
|
| Title | Concentration of Cytokine Interleukin 10 (IL-10) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 10 (IL-10) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
12.84
(13.25)
|
82.46
(184.34)
|
| Title | Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.94
(2.62)
|
44.04
(91.34)
|
| Title | Concentration of Cytokine Interleukin 12 (IL-12) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 12 (IL-12) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
4.36
(2.40)
|
28.36
(54.52)
|
| Title | Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
2.50
(1.77)
|
20.50
(39.60)
|
| Title | Concentration of Cytokine Interleukin 13 (IL-13) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine Interleukin 13 (IL-13) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
3.82
(3.42)
|
17.95
(35.29)
|
| Title | Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at Baseline. |
|---|---|
| Description | Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
11.87
(3.02)
|
13.88
(6.40)
|
| Title | Concentration of Cytokine Tumor Necrosis Factor Alpha (TNFa) in Blood as Measured by Immunoassay at 7 Weeks. |
|---|---|
| Description | Concentration of cytokine tumor necrosis factor alpha (TNFa) in blood as measured using Millipore Multiplex Human Cytokine Panel assay. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Blood was collected for this outcome from only 18 subjects. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 7 |
| Mean (Standard Deviation) [picogram/milliliter] |
33.52
(71.72)
|
12.22
(6.02)
|
| Title | Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at Baseline |
|---|---|
| Description | Total Fat Mass as measured by dual energy xray absorptiometry at the baseline study visit |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 24 subjects were able to complete this outcome measure at the baseline study visit. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 12 |
| Mean (Standard Deviation) [grams] |
20513.50
(13044.73)
|
18227.33
(10470.48)
|
| Title | Fat Mass as Measured by Dual Energy XRay Absorptiometry (DEXA) at 7 Weeks |
|---|---|
| Description | Total fat mass as measured by Dual Energy XRay Absorptiometry (DEXA) at the 7 week study visit. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 24 subjects began the study, 2 were dis-enrolled, 22 subjects finished the study. All 22 subjects completed this outcome measure at 7 weeks. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 10 |
| Mean (Standard Deviation) [grams] |
17616.58
(12513.32)
|
16776.60
(10989.56)
|
| Title | Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at Baseline |
|---|---|
| Description | The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99. |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 9 |
| Mean (Standard Deviation) [units on a scale] |
47.73
(27.87)
|
52.22
(23.60)
|
| Title | Quality of Life Measurement as Measured by Medical Outcome Study - Short Form 36 at 7 Weeks |
|---|---|
| Description | The Medical Outcome Study - Short Form 36 (MOS-SF-36) is a questionnaire developed by RAND Health to measure patient self-reported quality of life. Data presented is a subset of the questionnaire, Scale of General Health. The range for the subset presented (General Health) is 0 - 100, with 100 being better perceived health and 0 being worst perceived health. The national average of the MOS-36 General Health Subscale is reported as 56.99 |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 21 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 10 |
| Mean (Standard Deviation) [Units on a scale] |
52.73
(22.73)
|
46.50
(14.54)
|
| Title | Personal Perception of Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form at Baseline |
|---|---|
| Description | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 21 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 10 |
| Mean (Standard Deviation) [Units on a scale] |
12.73
(25.48)
|
21.40
(21.27)
|
| Title | Personal Perceptual Fatigue Measured by Multidimensional Fatigue Symptom Inventory at 7 Weeks |
|---|---|
| Description | Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF) from the Moffitt Cancer Center, University of South Florida The MFSI-SF is a 30 question assessment designed to assess the principal manifestations of fatigue. There 5 subscales used to calculate a total score. The subscales are: General Fatigue, Physical Fatigue, Emotional Fatigue, Mental Fatigue, and Vigor (an estimate of the patient's energy level). The total score is calculated with the equation: (general + physical + emotional + mental) - vigor = total score. The range of the total score is -24 to 96, with the higher the number meaning more fatigue. |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 9 |
| Mean (Standard Deviation) [Units on a scale] |
18.73
(24.18)
|
26.11
(19.73)
|
| Title | Mood Measured by Profile of Mood States at Baseline |
|---|---|
| Description | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). |
| Time Frame | baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 22 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 11 |
| Mean (Standard Deviation) [units on a scale] |
30.73
(50.67)
|
32.55
(23.74)
|
| Title | Mood as Measured by Profile of Mood States at 7 Weeks |
|---|---|
| Description | Profile of Mood States (POMS) is a questionnaire by MultiHealth Systems, that measures mood. In this 65 item questionnaire, subjects are asked to rate their feelings toward a statement from 0-4, with 0 being "not at all' and 4 being "extremely". There are 6 subscales which include, tension-anxiety, depression, anger-hostility, vigor, fatigue, and confusion. To calculate the total mood disturbance, which is what is reported here, the subscales tension-anxiety, depression, anger-hostility, fatigue and confusion are summed and vigor is subtracted. The scale range for total mood disturbance is 200 (worst) to -32 (best). |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 11 | 9 |
| Mean (Standard Deviation) [Units on a scale] |
28.82
(44.18)
|
35.78
(36.81)
|
| Title | Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at Baseline |
|---|---|
| Description | Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). |
| Time Frame | Baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| 19 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [scores on a scale] |
18.83
(3.50)
|
30.48
(31.63)
|
| Title | Quality of Life as Measured by Functional Assessment of Cancer Therapy - General Questionnaire at 7 Weeks |
|---|---|
| Description | Functional Assessment of Cancer Therapy - General (FACT-G) is a patient-reported questionnaire of quality of life. The 27 item questionnaire is separated into 4 subscales, physical well-being, social/family well-being, emotional well-being, functional well-being. These subscales are summed to calculate total score. The range for FACT-G is 0 (worst quality of life) to 108 (best quality of life). |
| Time Frame | 7 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 subjects completed this questionnaire at this time point. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 9 | 10 |
| Mean (Standard Deviation) [scores on a scale] |
20.11
(4.04)
|
24.97
(20.18)
|
| Title | 1-year Survival |
|---|---|
| Description | Number of participants who survived one year post study. |
| Time Frame | 1 year post study |
Outcome Measure Data
| Analysis Population Description |
|---|
| 12 subjects started each group. 2 subjects withdrew after baseline from the testosterone group. |
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone |
|---|---|---|
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate |
| Measure Participants | 12 | 10 |
| Count of Participants [Participants] |
7
58.3%
|
6
50%
|
Adverse Events
| Time Frame | 7 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone | ||
| Arm/Group Description | Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone: Standard of Care Chemotherapy and/or Radiation plus Placebo (Saline) Testosterone | Patients receive standard of care chemotherapy and/or radiation plus testosterone intramuscularly (IM) weekly for 7 weeks. Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate: Arm II: Standard of Care Chemotherapy and/or Radiation plus Testosterone Enanthate | ||
All Cause Mortality |
||||
| Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 0/12 (0%) | ||
Serious Adverse Events |
||||
| Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/12 (50%) | 6/12 (50%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia Requiring Tranfusion | 5/12 (41.7%) | 9 | 3/12 (25%) | 6 |
| Gastrointestinal disorders | ||||
| Duodenal Ulcer | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| General disorders | ||||
| Anaphylactic shock | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Sycope | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Infections and infestations | ||||
| Pneumonia | 0/12 (0%) | 0 | 2/12 (16.7%) | 2 |
| Vascular disorders | ||||
| Cerebrovascular Accident | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Deep Vein Thrombosis | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Arm I: Standard of Care Therapy + Placebo Testosterone | Arm II: Standard of Care Therapy + Testosterone | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/12 (50%) | 3/12 (25%) | ||
| Blood and lymphatic system disorders | ||||
| Thrombocytosis | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Hyponatremia | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Metastatic Bowel Obstruction | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| General disorders | ||||
| Dysphagia | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Infections and infestations | ||||
| Fever | 2/12 (16.7%) | 2 | 0/12 (0%) | 0 |
| Neutropenic Fever | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 |
| Psychiatric disorders | ||||
| Altered Mental State | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Renal and urinary disorders | ||||
| Urinary Tract Infection | 4/12 (33.3%) | 5 | 2/12 (16.7%) | 2 |
| Reproductive system and breast disorders | ||||
| Vesicovaginal Fistula | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Melinda Sheffield-Moore |
|---|---|
| Organization | University of Texas Medical Branch |
| Phone | 409-772-8707 |
| melmoore@utmb.edu |
Responsible Party:
The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier:
NCT00878995
Other Study ID Numbers:
- 06-073/10-207
- R01CA127971
- CDR0000629579
- GCRC#724/819
First Posted:
Apr 9, 2009
Last Update Posted:
Mar 12, 2018
Last Verified:
Mar 1, 2018