Improving Patient-Important Outcomes With Testosterone Replacement in Hypogonadal Men With a Prior History of Cancer
Seattle Institute for Biomedical and Clinical Research
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.
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…
Eligibility
- Age range
- 18–54 years
- Sex
- Male
- Healthy volunteers
- No
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 \<348 ng/dl and/or free testosterone \<70 pg/ml. The lower limits of the normal range for total testosterone in healthy young men (age 19-40 years), is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample97.…
Interventions
- DrugTestosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]
first two doses four weeks apart; following three more doses every ten weeks.
- Otherplacebo
first two doses four weeks apart; following three more doses every ten weeks.
Locations (2)
- Brigham and Women's HospitalBoston, Massachusetts
- Veterans Affairs Puget Sound Health Care SystemSeattle, Washington