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

Active:	Yes
Cancer Type:	Solid Tumor	NCT ID:	NCT04301765
Trial Phases:	Phase II	Protocol IDs:	AG061558 (primary) NCI-2020-06783
Eligibility:	55 Years and older, Male and Female	Study Type:	Supportive care
Study Sponsor:	Seattle Institute for Biomedical and Clinical Research
NCI Full Details:	http://clinicaltrials.gov/show/NCT04301765

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.

Objectives

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.

Treatment Sites in Georgia

Georgia Cancer Center at Augusta University
1411 Laney Walker Boulevard
Augusta, GA 30912
www.augusta.edu/cancer/

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.