Dexamethasone for Symptom Burden in Advanced Cancer Patients

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00489307
Collaborator
American Cancer Society, Inc. (Other)
132
2
2
192
66
0.3

Study Details

Study Description

Brief Summary

The goal of this clinical research study is to learn if dexamethasone can help to control symptoms such as fatigue, pain, nausea, weight loss, loss of appetite, sleep problems, and/or depression in patients with advanced cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Dexamethasone decreases inflammation and also suppresses the immune system.

If you are found to be eligible for this study, you will be randomly assigned (as in the toss of a coin) to receive either dexamethasone or a placebo by mouth in the morning and at night with food every day for 14 days. A placebo is a substance that looks like the study drug but which has no active ingredients. You will have an equal chance of being placed in either of the 2 groups. You, the medical staff, and researchers will not know to which group you have been assigned.

Beginning on Day 15 [± 3 days], regardless of if you were assigned to the dexamethasone or placebo group during the first 14 days, you will begin receiving the dexamethasone. On Days 15-21, you will receive dexamethasone 2 times a day. On Days 22-28 you will continue to take dexamethasone 2 times a day, but it will be at a lower dose level.

If you develop intolerable side effects while on this study, the medication will be stopped and you will be removed from the study.

You will be asked to return to the outpatient clinic on Days 8 [± 3 days], 15 [± 3 days] , 22 [± 3 days], and 29 [± 3 days] to answer a questionnaire about your cancer diagnosis, the medication you are taking, and the symptoms you are having (for example, pain, fatigue, nausea, appetite problems, sleep problems, depression, and your overall sense of well-being). The questionnaire will take approximately 30 minutes to complete. Blood (about 1 tablespoon) will be drawn to measure protein levels and to check the iron level in your blood. If you are unable to return to the clinic on days 8, 15, 22, or 29; the assessments will be done by the research nurse by phone; the blood work will not be done.

You will be considered off-study on Day 29 [ ± 3 days]. All study patients will have a 2 week follow-up on day 43 [± 3 days] after study drug has been discontinued, for safety and toxicity assessments. If you are unable to return to the clinic on day 43, the research nurse will do the safety and toxicity assessment by phone.

This is an investigational study. Dexamethasone has been approved by the FDA and is a commercially available drug. It is FDA approved at this dose level. Its use in this study, for this purpose, is investigational. About 160 patients will take part in this study. Up to 110 will be enrolled at the University of Texas (UT) MD Anderson Cancer Center. The other sites participating in this study are Lyndon Baines Johnson [LBJ] breast oncology clinic Houston Texas, and Four Seasons Hospice in Flat Rock, North Carolina.

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer
Actual Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexamethasone

Dexamethasone 4 mg orally two times a day for 14 days. On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.

Drug: Dexamethasone
4 mg PO (by mouth) twice daily x 14 days
Other Names:
  • Decadron
  • Placebo Comparator: Placebo

    Placebo by mouth (PO) twice daily for 14 days. On day 15 [ ± 3 days], all patients receive dexamethasone 4 mg orally twice a day for 7 days, and then the dose of dexamethasone tapered to 2 mg orally twice a day between days 22 to 28.

    Drug: Dexamethasone
    4 mg PO (by mouth) twice daily x 14 days
    Other Names:
  • Decadron
  • Drug: Placebo
    Placebo PO twice daily x 14 days

    Outcome Measures

    Primary Outcome Measures

    1. Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores [Baseline to Day 15]

      FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.

    Secondary Outcome Measures

    1. Edmonton Symptom Assessment System (ESAS) Pain [Baseline to day 15]

      ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15.

    2. Edmonton Symptom Assessment System (ESAS) Nausea [Baseline to Day 15]

      ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15

    3. Edmonton Symptom Assessment System (ESAS) Appetite [Baseline to day 15]

      ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15

    4. Hospital Anxiety and Depression Scale (HADS) Anxiety [Baseline to day 15]

      HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.

    5. Hospital Anxiety and Depression Scale (HADS) Depression [Baseline to day 15]

      HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Present with 3 or more symptoms during the last 24 hours (Pain, fatigue, chronic nausea, and anorexia/cachexia, sleep problems, depression or poor appetite), with an average intensity of >/= 4 on a 0-10 scale, in which 0= no symptom, and 10= worst possible symptom,

    2. No clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment Scale (MDAS) score of 13 or less at baseline

    3. Must be 18 years of older

    4. No longer a candidate for aggressive anticancer therapy-such as receptor blockers (Iressa, etc.) Patients on oral or palliative chemotherapy are eligible for study if approved by primary oncologist prior to inclusion. Patients who are receiving IV chemotherapy are eligible for study if approved by primary oncologist and they have completed 1st line of chemotherapy and are deemed stable by primary oncologist. The PI of this study will obtain and document approval from the primary oncologist in the patient's study documents.

    5. Life expectancy =/> 30 days

    6. Must understand and sign written informed consent

    7. Patients on topical, or inhaled corticosteroids are eligible for study. If patients have been on oral corticosteroids for </= 7 days prior to inclusion of study they are eligible for study.

    Exclusion Criteria:
    1. Allergy to Dexamethasone

    2. Inability to complete the baseline assessment forms

    3. Patients currently taking Megestrol, and not off drug for > 7 days

    4. Anemia as defined as < 9 hemoglobin

    5. Known history of human immunodeficiency virus (HIV)

    6. Neutropenia as defined by an absolute neutrophil count (ANC) of < 1500 cells/mm

    7. Patients with a history of diabetes will be excluded.

    8. All major surgeries such as thoracotomy etc., that requires wound healing within last 2 weeks

    9. Those who are currently receiving oral corticosteroid therapy or who have been on corticosteroid therapy >/= 8 days prior to study inclusion

    10. Sepsis and/or acute, chronic, or ongoing infections

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lyndon Baines Johnson Hospital Houston Texas United States 77030
    2 University of Texas MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • American Cancer Society, Inc.

    Investigators

    • Principal Investigator: Sriram Yennurajalingam, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00489307
    Other Study ID Numbers:
    • 2005-0816
    • NCI-2012-01646
    • MRSG-07-001-01-CCE
    First Posted:
    Jun 21, 2007
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by M.D. Anderson Cancer Center
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Patients with advanced cancer with >= three Cancer related fatigue symptoms (ie, fatigue, pain, nausea, loss of appetite, depression, anxiety, or sleep disturbance) >= 4 of 10 on the Edmonton Symptom Assessment Scale (ESAS) were eligible.
    Pre-assignment Detail
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Period Title: Overall Study
    STARTED 67 65
    COMPLETED 43 41
    NOT COMPLETED 24 24

    Baseline Characteristics

    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo Total
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days. Total of all reporting groups
    Overall Participants 67 65 132
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    60.5
    60
    60
    Sex: Female, Male (Count of Participants)
    Female
    42
    62.7%
    28
    43.1%
    70
    53%
    Male
    25
    37.3%
    37
    56.9%
    62
    47%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    1.5%
    6
    9.2%
    7
    5.3%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    13
    19.4%
    10
    15.4%
    23
    17.4%
    White
    53
    79.1%
    49
    75.4%
    102
    77.3%
    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
    67
    100%
    65
    100%
    132
    100%
    Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (score on a scale) [Mean (Standard Deviation) ]
    FACIT-F Subscale Score
    18.4
    (10.47)
    21.57
    (9.11)
    19.64
    (9.98)
    FAACT Subscale score
    23.91
    (8.28)
    25.69
    (8.93)
    24.84
    (8.58)
    FACIT_F- Total score
    88.66
    (19.9)
    77.1
    (23.83)
    80.85
    (22.2)
    Hospital Anxiety and Depression Scale (HADS) (score on a scale) [Mean (Standard Deviation) ]
    HADS Anxiety score
    7.47
    (4.18)
    7.46
    (3.9)
    7.46
    (4.03)
    HADS Depression score
    9.03
    (5.72)
    4.22
    (7.94)
    8.5
    (3.8)
    Edmonton Symptom Assessment System (ESAS) (score on a scale) [Mean (Standard Deviation) ]
    ESAS Pain
    5.72
    (2.43)
    5.14
    (2.8)
    5.43
    (2.63)
    ESAS Fatigue
    7.38
    (1.89)
    5.14
    (2.8)
    7.05
    (1.89)
    ESAS Nausea
    2.64
    (2.73)
    2.28
    (2.76)
    2.46
    (2.74)
    ESAS Depression
    3.13
    (3.16)
    3.36
    (3.11)
    3.24
    (3.13)
    ESAS Anxiety
    3.64
    (3.27)
    3.69
    (2.91)
    3.66
    (3.08)
    ESAS Drowsiness
    4.14
    (3.19)
    4.2
    (2.68)
    4.17
    (2.94)

    Outcome Measures

    1. Primary Outcome
    Title Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Subscale Scores
    Description FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. It was measured as change in symptom score from Baseline to Day 15.
    Time Frame Baseline to Day 15

    Outcome Measure Data

    Analysis Population Description
    A total of 48 participants were excluded from the analysis for various reasons.
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Measure Participants 43 41
    Mean (Standard Deviation) [score on a scale]
    9
    (10.3)
    3.1
    (9.59)
    2. Secondary Outcome
    Title Edmonton Symptom Assessment System (ESAS) Pain
    Description ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15.
    Time Frame Baseline to day 15

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Measure Participants 43 41
    Mean (Standard Deviation) [score on a scale]
    -1.35
    (3.11)
    -0.17
    (2.66)
    3. Secondary Outcome
    Title Edmonton Symptom Assessment System (ESAS) Nausea
    Description ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15
    Time Frame Baseline to Day 15

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Measure Participants 43 41
    Mean (Standard Deviation) [score on a scale]
    -1.08
    (2.95)
    -0.36
    (3.17)
    4. Secondary Outcome
    Title Edmonton Symptom Assessment System (ESAS) Appetite
    Description ESAS was used to assess 10 symptoms commonly experienced by patients with cancer during the previous 24 hour. The severity of each symptom was rated on a numeric scale of 0 to 10 (0, no symptoms; 10, worst possible severity). Higher the score higher the severity of the symptom is. It was measured as change in symptom score from Baseline to Day 15
    Time Frame Baseline to day 15

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Measure Participants 43 41
    Mean (Standard Deviation) [score on a scale]
    -2.19
    (3.78)
    -0.63
    (3.11)
    5. Secondary Outcome
    Title Hospital Anxiety and Depression Scale (HADS) Anxiety
    Description HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.
    Time Frame Baseline to day 15

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Measure Participants 43 41
    Mean (Standard Deviation) [score on a scale]
    -0.66
    (3.45)
    -1
    (3.54)
    6. Secondary Outcome
    Title Hospital Anxiety and Depression Scale (HADS) Depression
    Description HADS is a self-report rating scale of 14 items on a 4-point Likert scale (range 0-3). It is designed to measure anxiety and depression (7 items for each subscale). The total range is from 0-21. The higher the score, the higher the severity of symptoms. It was measured as change in symptom score from Baseline to Day 15.
    Time Frame Baseline to day 15

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    Measure Participants 43 41
    Mean (Standard Deviation) [score on a scale]
    -1.39
    (3.59)
    -0.31
    (3.9)

    Adverse Events

    Time Frame Baseline up to Day 15
    Adverse Event Reporting Description Grading of adverse events as per National Cancer Institute Common Toxicity Criteria (version 3.0).
    Arm/Group Title Intervention Group (Dexamethasone) (Control Group) Placebo
    Arm/Group Description Dexamethasone 4 mg orally two times a day for 14 days. Placebo by mouth (PO) twice daily for 14 days.
    All Cause Mortality
    Intervention Group (Dexamethasone) (Control Group) Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/43 (2.3%) 1/41 (2.4%)
    Serious Adverse Events
    Intervention Group (Dexamethasone) (Control Group) Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/43 (0%) 0/41 (0%)
    Other (Not Including Serious) Adverse Events
    Intervention Group (Dexamethasone) (Control Group) Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 18/43 (41.9%) 11/41 (26.8%)
    Gastrointestinal disorders
    Dysphagia 1/43 (2.3%) 0/41 (0%)
    General disorders
    Infection 4/43 (9.3%) 1/41 (2.4%)
    Edema 1/43 (2.3%) 4/41 (9.8%)
    Musculoskeletal and connective tissue disorders
    Fatigue 8/43 (18.6%) 6/41 (14.6%)
    Nervous system disorders
    Pain 18/43 (41.9%) 11/41 (26.8%)
    Insomnia 3/43 (7%) 6/41 (14.6%)
    Dizziness 1/43 (2.3%) 1/41 (2.4%)
    Neuropathy 1/43 (2.3%) 0/41 (0%)
    Somnolence 0/43 (0%) 4/41 (9.8%)
    Nausea/Vomiting 1/43 (2.3%) 3/41 (7.3%)
    Blurred Vision 1/43 (2.3%) 0/41 (0%)
    Depression 1/43 (2.3%) 0/41 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 0/43 (0%) 2/41 (4.9%)
    Dyspnea 0/43 (0%) 6/41 (14.6%)

    Limitations/Caveats

    [Not Specified]

    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.

    Results Point of Contact

    Name/Title Dr. Sriram Yennu, Professor, Palliative Care Med
    Organization UT MD Anderson Cancer Center
    Phone (713) 792-3938
    Email syennu@mdanderson.org
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00489307
    Other Study ID Numbers:
    • 2005-0816
    • NCI-2012-01646
    • MRSG-07-001-01-CCE
    First Posted:
    Jun 21, 2007
    Last Update Posted:
    Dec 21, 2021
    Last Verified:
    Nov 1, 2021