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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00631137
• Other study ID #: J0634
• Secondary ID: P30CA006973JHOC-
• Status: Terminated
• Phase: N/A
• Start date: January 2008
• Est. completion date: September 2008

Study information

• Verified date: August 2018
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Musculoskeletal Complications
• Nervous System Neoplasms

Intervention

Drug:
• testosterone gel applied to skin
Application of testosterone gel

Dietary Supplement:
• whey powder protein

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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		baseline and at 1, 3, 5, and 7 months
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		baseline and at 1, 3, 5, and 7 months
Secondary	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
Secondary	Leg Muscle Mass as Assessed by CT Scan at Baseline and at 3 and 7 Months		baseline and at 3 and 7 months
Secondary	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
Secondary	Side Effects of Testosterone Gel as Assessed by Frequency of Adverse Events, Including Laboratory Abnormalities		while receiving treatment
Secondary	Serum Total Testosterone Levels as Assessed at Baseline and at 1, 3, and 7 Months		baseline and at 1, 3, and 7