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NCT04049331
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
Conditions: Hypogonadism, Male, Fatigue Syndrome, Chronic
Sex: Male
Ages: 18 Years – 54 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 240
Sponsor: Seattle Institute for Biomedical and Clinical Research
Location: Brigham and Women's Hospital Boston Massachusetts
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.
Eligibility Criteria
Inclusion Criteria:
* Cancer survivors who have received chemotherapy and/or radiation therapy for their cancer and are now in remission for at least one year
* Non-hormone-dependent cancer, including most solid tumors, lymphomas and leukemias
* Age: 18-54 years
* Serum testosterone, measured by mass spectrometry (gold standard method), of \
Source: ClinicalTrials.gov (NCT04049331). StuddyBuddy aggregates publicly available trial information.