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

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.

Study Overview

• Status: Terminated
• Conditions: Brain and Central Nervous System Tumors; Musculoskeletal Complications
• Intervention / Treatment: Dietary supplement: whey powder protein; Drug: testosterone gel applied to skin

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1: Control Group; whey protein powder	Dietary supplement: whey powder protein
Active Comparator: ARM 2 : Treatment Group; Testosterone Gel (10g pouch/day) applied to skin	Drug: testosterone gel applied to skin; Application of testosterone gel

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Jaishri O. Blakeley, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: March 6, 2008
• First Submitted That Met QC Criteria: March 6, 2008
• First Posted (Estimate): March 7, 2008

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 24, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; musculoskeletal complications
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: J0634; P30CA006973 (U.S. NIH Grant/Contract); JHOC-J0634 (Other Identifier: Johns Hopkins University SKCCC); NA_00003125 (Other Identifier: Johns Hopkins University IRB); CDR0000584274 (Other Identifier: other)