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

Johns Hopkins Medicine

Status: Terminated

Conditions: Musculoskeletal Complications; Brain and Central Nervous System Tumors

Treatments: Drug: testosterone gel applied to skin; Dietary Supplement: whey powder protein

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00631137

J0634

NA_00003125 (Other Identifier)

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-J0634 (Other Identifier)

CDR0000584274 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

1 participants in 2 patient groups, including a placebo group

Arm 1: Control Group

Placebo Comparator group

Description:

whey protein powder

Treatment:

Dietary Supplement: whey powder protein

ARM 2 : Treatment Group

Active Comparator group

Description:

Testosterone Gel (10g pouch/day) applied to skin

Treatment:

Drug: testosterone gel applied to skin