Testosterone Gel in Preventing Weakness Caused by Steroid Therapy in Men Receiving Glucocorticoids for Newly Diagnosed High-Grade Glioma

This study has been terminated.
(Study terminated due to low accrual.)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00631137
First received: March 6, 2008
Last updated: September 29, 2008
Last verified: March 2008
  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.


Condition Intervention
Brain and Central Nervous System Tumors
Musculoskeletal Complications
Drug: testosterone gel
Procedure: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Supportive Care
Official Title: A Randomized, Controlled Comparative Trial to Determine if Testosterone Gel Prevents Steroid Related Weakness in Brain Cancer Patients

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]
  • Performance on timed functional tests (TFT) as assessed at baseline and at 1, 3, 5, and 7 months [ Designated as safety issue: No ]
  • Leg muscle mass as assessed by CT scan at baseline and at 3 and 7 months [ Designated as safety issue: No ]
  • Activities of daily living as assessed by the Health Assessment Questionnaire-Disability Index at baseline and at 1, 3, 5, and 7 months [ Designated as safety issue: No ]
  • Side effects of testosterone gel as assessed by frequency of adverse events, including laboratory abnormalities [ Designated as safety issue: Yes ]
  • Serum total testosterone levels as assessed at baseline and at 1, 3, and 7 months [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631137

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Jaishri O. Blakeley, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00631137     History of Changes
Other Study ID Numbers: CDR0000584274, JHOC-J0634, JHOC-NA_00003125
Study First Received: March 6, 2008
Last Updated: September 29, 2008
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
musculoskeletal complications
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult giant cell glioblastoma
adult glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Glucocorticoids
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on August 01, 2014