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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients

Conditions
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Brain and Central Nervous System Tumors, Musculoskeletal Complications

Intervention / Treatment
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* Drug: testosterone gel applied to skin
* Dietary Supplement: whey powder protein


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months |  | baseline and at 3 and 7 months | 
| 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 | 
| Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities |  | while receiving treatment | 
| Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months |  | baseline and at 1, 3, and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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musculoskeletal complications, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma