Clinical trial NCT00631137: Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men With Glioma
Official title: A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-03-07
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
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
timeFrame: baseline and at 1, 3, 5, and 7 months
Secondary outcomes:
measure: 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
timeFrame: baseline and at 1, 3, 5, and 7 months
measure: Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months
timeFrame: baseline and at 1, 3, 5, and 7 months
measure: Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months
timeFrame: baseline and at 3 and 7 months
measure: Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months
timeFrame: baseline and at 1, 3, 5, and 7 months
measure: Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities
timeFrame: while receiving treatment
measure: Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months
timeFrame: baseline and at 1, 3, and 7
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Jaishri O. Blakeley, MD
role: STUDY_CHAIR
References: