A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
- 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.
- 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
- 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
Allocation: Randomized, Primary Purpose: Supportive Care
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
Jaishri O. Blakeley, MD
Sidney Kimmel Comprehensive Cancer Center
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|