NCT04301765

Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Seattle Institute for Biomedical and Clinical Research · Academic / Other
• Sex: Male
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.

Detailed description

The overall objective is to conduct a double-blind, randomized, placebo-controlled, parallel group trial to determine the efficacy of 6 months of physiological testosterone replacement therapy in improving cancer related fatigue, sexual dysfunction, and body composition and muscle function in men 55 years and older with solid or hematologic (blood) cancers, who report fatigue and have testosterone deficiency. There will be 5 study visits: 1) Screening, 2) Baseline, 3) 2-Week Dose Adjustment Visit, 4) Three-month visit (Week 12), and 5) Six-month visit. Testosterone or placebo gels will be applied by eligible trial participants at home; participants will be trained on gel application procedures by research personnel.

Conditions

• Hypogonadism, Male
• Cancer
• Fatigue

Interventions

Type	Name	Description
DRUG	testosterone 1.62% gel	The gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months
OTHER	placebo gel	The gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months

Timeline

• Start date: 2021-01-12
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2020-03-10
• Last updated: 2026-03-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study