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

NCT00631137 | Terminated Results

• 5 other identifiers: J0634P30CA006973JHOC-J0634NA_00003125CDR0000584274
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain and Central Nervous System Tumors; Musculoskeletal Complications

Keywords

musculoskeletal complications; adult anaplastic astrocytoma; adult anaplastic oligodendroglioma; adult giant cell glioblastoma; adult glioblastoma; adult gliosarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Arm 1: Control Group

PLACEBO COMPARATOR

whey protein powder

Dietary Supplement: whey powder protein

ARM 2 : Treatment Group

ACTIVE COMPARATOR

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

Drug: testosterone gel applied to skin

Interventions

testosterone gel applied to skin DRUG

Application of testosterone gel

ARM 2 : Treatment Group

whey powder protein DIETARY_SUPPLEMENT

Arm 1: Control Group

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Oligodendroglioma; Glioblastoma; Gliosarcoma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Limitations and Caveats

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

Results Point of Contact

• Title: Jaishri Blakeley
• Organization: Johns Hopkins

jblakel3@jhmi.edu

410-955-8837

Study Officials

• Jaishri O. Blakeley, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2008
• First Posted: March 7, 2008
• Study Start: January 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 27, 2018
• Results First Posted: August 27, 2018

Record last verified: 2018-08

Locations

US (1)