A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
18 Years
N/A
Male
Brain and Central Nervous System Tumors, Musculoskeletal Complications
Trial Information
A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Supportive Care
Outcome Measure:
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
Safety Issue:
No
Principal Investigator
Jaishri O. Blakeley, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
Unspecified
Study ID:
CDR0000584274
NCT ID:
NCT00631137
Start Date:
January 2008
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- Musculoskeletal Complications
- musculoskeletal complications
- adult anaplastic astrocytoma
- adult anaplastic oligodendroglioma
- adult giant cell glioblastoma
- adult glioblastoma
- adult gliosarcoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
