Brain and Central Nervous System Tumors, Musculoskeletal Complications
Conditions
Keywords
musculoskeletal complications, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
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.
Interventions
DRUGtestosterone gel applied to skin
Application of testosterone gel
DIETARY_SUPPLEMENTwhey powder protein
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | baseline and at 1, 3, 5, and 7 months |
Secondary
| Measure | Time frame |
|---|---|
| Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months | baseline and at 1, 3, 5, and 7 months |
| Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months | baseline and at 3 and 7 months |
| 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 | baseline and at 1, 3, 5, and 7 months |
| Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities | while receiving treatment |
| Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months | baseline and at 1, 3, and 7 |
| Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months | baseline and at 1, 3, 5, and 7 months |
Countries
United States
Participant flow
Recruitment details
outpatient clinic
Participants by arm
| Arm | Count |
|---|---|
| ARM 2 : Treatment Group Androgel (10g pouch/day)
testosterone gel :
questionnaire administration : | 1 |
| Arm 1: Control Group whey protein powder
questionnaire administration : | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | ARM 2 : Treatment Group | Total |
|---|---|---|
| Age, Customized | 29 years | 29 years |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
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
Time frame: baseline and at 1, 3, 5, and 7 months
Population: Only 1 subject accrued. Not enough data to analysis
Secondary
Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months
Time frame: baseline and at 1, 3, 5, and 7 months
Population: only 1 subject enrolled. Not enough to do analysis
Secondary
Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months
Time frame: baseline and at 3 and 7 months
Population: Only 1 subject accrued. Not enough data to analysis
Secondary
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
Time frame: baseline and at 1, 3, 5, and 7 months
Population: Only 1 subject accrued. Not enough data to analysis
Secondary
Performance on Timed Functional Tests (TFT) as Assessed at Baseline and at 1, 3, 5, and 7 Months
Time frame: baseline and at 1, 3, 5, and 7 months
Population: Only 1 subject accrued. Not enough data to analysis
Secondary
Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months
Time frame: baseline and at 1, 3, and 7
Population: only 1 subject enrolled. Not enough to do analysis
Secondary
Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities
Time frame: while receiving treatment
Population: only 1 subject enrolled. Not enough to do analysis