Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study terminated due to low accrual.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Musculoskeletal Complications | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| testosterone gel applied to skin | Drug | — | UNRESOLVED |
| whey powder protein | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm 1: Control Group
- description
- whey protein powder
- interventionNames
- Dietary Supplement: whey powder protein
- type
- ACTIVE_COMPARATOR
- label
- ARM 2 : Treatment Group
- description
- Testosterone Gel (10g pouch/day) applied to skin
- interventionNames
- Drug: testosterone gel applied to skin
Primary outcomes (1)
- measure
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available