NCT04049331

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Seattle Institute for Biomedical and Clinical Research · Academic / Other
• Sex: Male
• Age: 18 Years – 54 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this study is to evaluate the effect of a testosterone drug called Depo-Testosterone (or 'testosterone cypionate'), an FDA-approved drug for improving fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity in young cancer survivors who report fatigue and have low testosterone. Main hypothesis is that Testosterone administration in young male cancer survivors who are in remission for at least 1 year, report cancer-related fatigue and have symptomatic testosterone deficiency will be associated with greater improvements in fatigue scores compared with placebo.

Detailed description

The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, muscle strength and physical activity in a double-blind, randomized, placebo-controlled trial in young cancer survivors who report fatigue and have testosterone deficiency. Fatigue is one of the most prevalent and debilitating symptoms in men with cancer affecting 70-100% of patients irrespective of their age. Cancer-related fatigue is experienced by patients not only during active cancer treatment, but is also highly prevalent in cancer survivors who exhibit persistent fatigue months to years after the end of their treatment with the highest prevalence being in recipients of chemotherapy and/or radiation therapy. In addition to fatigue, sexual dysfunction is also highly prevalent in male cancer survivors. Male cancer survivors also have increased fat mass and decreased lean body mass, a phenotype that predisposes them to reduced muscle strength. This phenotype of fatigue, sexual dysfunction and adverse body composition is commonly encountered in non-cancer patient populations with testosterone deficiency, a condition which is also highly prevalent (50-90%) in cancer survivors. Pivotal trials of testosterone replacement therapy in non-cancer patient populations have shown an improvement in fatigue, sexual function and body composition in men randomized to testosterone compared with placebo. However, the efficacy of testosterone replacement therapy on cancer-related fatigue has not been studied.

Conditions

• Hypogonadism, Male
• Fatigue Syndrome, Chronic

Interventions

Type	Name	Description
DRUG	Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]	first two doses four weeks apart; following three more doses every ten weeks.
OTHER	placebo	first two doses four weeks apart; following three more doses every ten weeks.

Timeline

• Start date: 2021-03-22
• Primary completion: 2027-01-30
• Completion: 2027-01-30
• First posted: 2019-08-08
• Last updated: 2025-03-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study