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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender Male
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00631137
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jaishri O. Blakeley, MD
Principal Investigator Affiliation Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Brain and Central Nervous System Tumors, Musculoskeletal Complications
Additional Details

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.#46;≥ 16 mg/day), Karnofsky performance status (≤ 80% vs.#46;> 80%), and age (≤ 50 years of age vs.#46; > 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.

Arms & Interventions

Arms

Placebo Comparator: Arm 1: Control Group

whey protein powder

Active Comparator: ARM 2 : Treatment Group

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

Interventions

Drug: - testosterone gel applied to skin

Application of testosterone gel

Dietary Supplement: - whey powder protein

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410