Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
Verified date | August 2018 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | ||
Secondary | 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 | ||
Secondary | Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months | baseline and at 3 and 7 months | ||
Secondary | 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 | ||
Secondary | Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities | while receiving treatment | ||
Secondary | Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months | baseline and at 1, 3, and 7 |
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