Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00631137
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 1
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Testosterone gel may be effective in preventing or lessening muscle weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.

PURPOSE: This randomized clinical trial is studying how well testosterone gel works in preventing weakness caused by steroid therapy in men receiving glucocorticoids for newly diagnosed high-grade glioma.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors; Musculoskeletal Complications	Drug: testosterone gel applied to skin; Dietary Supplement: whey powder protein	N/A

Detailed Description

OBJECTIVES:

Primary

• To determine if daily administration of testosterone gel can prevent the development or reduce the severity of muscle weakness in men receiving glucocorticoids for newly diagnosed high-grade glioma.

Secondary

• To compare the difference in percent change from baseline timed functional tests (TFT) between patients who are treated with testosterone gel and those who are not.

• To compare the difference in percent change from baseline activities of daily living as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) between patients who are treated with testosterone gel and those who are not.

• To compare the difference in percent change from baseline leg muscle mass as assessed by CT scan imaging between patients who are treated with testosterone gel and those who are not.

• To estimate the side effects of testosterone gel in these patients.

OUTLINE: Patients are stratified according to daily glucocorticoid dose (< 16 mg/day vs ≥ 16 mg/day), Karnofsky performance status (≤ 80% vs > 80%), and age (≤ 50 years of age vs > 50 years of age). Patients are randomized to 1 of 2 treatment arms.

• Arm I (control): Patients receive oral whey protein powder once daily for 7 months.

• Arm II (treatment): Patients apply topical testosterone gel to the shoulder, upper chest, or forearm once daily for 7 months.

Patients undergo strength testing and functional testing (TFT) and complete an activities of daily living questionnaire at baseline and at 1, 3, 5, and 7 months. Patients also undergo CT scan of the leg and laboratory testing at baseline and at 3 and 7 months. Testosterone levels are obtained at baseline and at 1, 3, and 7 months.

Patients complete a daily log of their glucocorticoid dose and to affirm compliance with therapy. Major clinical events related to underlying tumor (i.e., surgery, radiotherapy, initiating chemotherapy, concurrent antiepileptic therapy, deep vein thrombosis, pulmonary embolism, transfusions, seizures, pneumonia, and other forms of infection) are also recorded.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Arm 1: Control Group whey protein powder	Dietary Supplement: whey powder protein
Active Comparator: ARM 2 : Treatment Group Testosterone Gel (10g pouch/day) applied to skin	Drug: testosterone gel applied to skin; Application of testosterone gel

Outcome Measures

Primary Outcome Measures

1. Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months [baseline and at 1, 3, 5, and 7 months]

Secondary Outcome Measures

1. Muscle Strength Testing in Other Proximal Muscles (i.e., Knee Extensors, Knee Flexors, Arm Abductors, Elbow Extensors and Flexors, and Neck Flexors) as Assessed by Dynamometry at Baseline and at 1, 3, 5, and 7 Months [baseline and at 1, 3, 5, and 7 months]

2. Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months [baseline and at 1, 3, 5, and 7 months]

3. Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months [baseline and at 3 and 7 months]

4. Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months [baseline and at 1, 3, 5, and 7 months]

5. Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities [while receiving treatment]

6. Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months [baseline and at 1, 3, and 7]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Newly diagnosed high-grade glioma, including the following subtypes:

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Glioblastoma multiforme

• Requires dexamethasone at a dose of > 4 mg/day to control symptoms of tumor-related edema at time of study enrollment AND has been on a stable dose of steroids for ≥ 5 days prior to study enrollment

• Completed ≥ 80% of prescribed radiotherapy

• Hypogonadal, defined as serum testosterone level < 350 ng/dL

• No history of prostate or breast cancer

• No benign prostatic hypertrophy requiring therapy OR AUA score of ≥ 8

• PSA ≤ 4 ng/mL

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%

• Able to keep daily records or has a care provider that agrees to keep daily records of drug administration

• No clinical history of congestive heart failure requiring therapy

• No psychotic disorder requiring active treatment

• No structured exercise program involving exercise for > 3 hours/week

• No polycythemia (i.e., hematocrit > 52%)

PRIOR CONCURRENT THERAPY:

• More than 6 months since prior androgen therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• National Cancer Institute (NCI)

Investigators

• Study Chair: Jaishri O. Blakeley, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00631137
• Other Study ID Numbers: J0634; P30CA006973; JHOC-J0634; NA_00003125; CDR0000584274
• First Posted: Mar 7, 2008
• Last Update Posted: Aug 27, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: musculoskeletal complications; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma
• Additional relevant MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Testosterone

Study Results

Participant Flow

Recruitment Details	outpatient clinic

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Period Title: Overall Study
STARTED	1	0
COMPLETED	0	0
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group	Total
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :	Total of all reporting groups
Overall Participants	1	0	1
Age, Customized (years) [Number]
Number [years]	29	29
Sex: Female, Male (Count of Participants)
Female	0 0%	0 NaN
Male	1 100%	1 Infinity
Region of Enrollment (participants) [Number]
United States	1 100%	1 Infinity

Outcome Measures

1. Primary Outcome

Title	Time to Event, Defined as ≥ 50% Loss of Strength in the Hip Flexors as Assessed by Dynamometry Peak Force Measures at Baseline and at 1, 3, 5, and 7 Months
Time Frame	baseline and at 1, 3, 5, and 7 months

Outcome Measure Data

Analysis Population Description

Only 1 subject accrued. Not enough data to analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

2. Secondary Outcome

Title	Muscle Strength Testing in Other Proximal Muscles (i.e., Knee Extensors, Knee Flexors, Arm Abductors, Elbow Extensors and Flexors, and Neck Flexors) as Assessed by Dynamometry at Baseline and at 1, 3, 5, and 7 Months
Time Frame	baseline and at 1, 3, 5, and 7 months

Outcome Measure Data

Analysis Population Description

Only 1 subject accrued. Not enough data to analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

3. Secondary Outcome

Title	Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months
Time Frame	baseline and at 1, 3, 5, and 7 months

Outcome Measure Data

Analysis Population Description

Only 1 subject accrued. Not enough data to analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

4. Secondary Outcome

Title	Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months
Time Frame	baseline and at 3 and 7 months

Outcome Measure Data

Analysis Population Description

Only 1 subject accrued. Not enough data to analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

5. Secondary Outcome

Title	Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months
Time Frame	baseline and at 1, 3, 5, and 7 months

Outcome Measure Data

Analysis Population Description

only 1 subject enrolled. Not enough to do analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

6. Secondary Outcome

Title	Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities
Time Frame	while receiving treatment

Outcome Measure Data

Analysis Population Description

only 1 subject enrolled. Not enough to do analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

7. Secondary Outcome

Title	Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months
Time Frame	baseline and at 1, 3, and 7

Outcome Measure Data

Analysis Population Description

only 1 subject enrolled. Not enough to do analysis

Arm/Group Title	ARM 2 : Treatment Group	Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :	whey protein powder questionnaire administration :
Measure Participants	0	0

Adverse Events

Time Frame	through study completion, up to 1 year
Adverse Event Reporting Description	The definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.
Arm/Group Title	ARM 2 : Treatment Group		Arm 1: Control Group
Arm/Group Description	Androgel (10g pouch/day) testosterone gel : questionnaire administration :		whey protein powder questionnaire administration :
All Cause Mortality
	ARM 2 : Treatment Group		Arm 1: Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Serious Adverse Events
	ARM 2 : Treatment Group		Arm 1: Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	ARM 2 : Treatment Group		Arm 1: Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/1 (100%)		0/0 (NaN)
Skin and subcutaneous tissue disorders
rash: acne/acneiform	1/1 (100%)	1	0/0 (NaN)	0

Limitations/Caveats

early termination, leading to only 1 subject enrolled, hence could NOT do data analysis

More Information

Certain Agreements

All Principal Investigators ARE 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.