Clinical trial NCT00631137
Conditions: Brain and Central Nervous System Tumors Musculoskeletal Complications
Keywords: musculoskeletal complications adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2008-01-01; Completion date: 2008-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

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.

Arms: arm 1: whey protein powder arm 2: Testosterone Gel (10g pouch/day) applied to skin
Interventions: intervention 1: testosterone gel applied to skin intervention 2: whey powder protein
Intervention descriptions: intervention 1: Application of testosterone gel intervention 2: None

Protocol documents: