Testosterone Replacement Therapy for Fatigue and Low Testosterone in Male Cancer Survivors Aged 18 to 54

What this Trial Is About

Researchers are studying the effects of testosterone replacement therapy using Depo-Testosterone testosterone cypionate in young male cancer survivors who experience fatigue and have low testosterone levels. This trial focuses on men in remission for at least one year who report cancer-related fatigue, aiming to see if testosterone treatment improves fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity. Fatigue and sexual dysfunction are common in male cancer survivors and may be linked to testosterone deficiency, a condition prevalent in this group but not yet studied in this context. The study compares testosterone undecanoate injections with a placebo in a double-blind, randomized, placebo-controlled design. Participants receive the first two doses four weeks apart, followed by three doses every ten weeks. The trial evaluates treatment effects over nine months, monitoring changes in fatigue, sexual function, body composition, mood, muscle strength, sleep quality, and daily physical activity. The research is sponsored by the Seattle Institute for Biomedical and Clinical Research and follows a phase 2 treatment model. Participants undergo screening to confirm eligibility, then receive either testosterone or placebo injections as per schedule. Researchers assess outcomes using standardized measures at intervals throughout the study. Safety is monitored via laboratory tests and symptom tracking. The total participation lasts nine months, during which fatigue and other patient-important outcomes are measured to understand the therapys impact.

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone