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Testosterone

Androgens

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Whey Protein

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

testosterone gel applied to skin

whey powder protein

Jaishri O. Blakeley, MD

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.

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.

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

A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients

National Cancer Institute (NCI)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

The definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov definition.

Androgel (10g pouch/day)

testosterone gel :

questionnaire administration :

ARM 2 : Treatment Group

whey protein powder

questionnaire administration :

Arm 1: Control Group

Total

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

No participants were assigned to the Control Group Arm

early termination, leading to only 1 subject enrolled, hence could NOT do data analysis

Jaishri Blakeley

Only 1 subject accrued. Not enough data to analysis

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

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

Performance on Timed Functional Tests (TFT) as Assessed at 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

only 1 subject enrolled. Not enough to do analysis

Activities of Daily Living as Assessed by the Health Assessment Questionnaire-Disability Index at Baseline and at 1, 3, 5, and 7 Months

Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities

Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months

Overall Study

Spots Global Cancer Trial Database for whey powder protein