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About
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.
Full 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.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown origin)
Men with brain cancer (potential cognitive impairment)
Use of anabolic agents (testosterone, dehydroepiandrosterone, growth hormone) within the past 6 months
Appetite stimulating agents e.g. megestrol acetate within the past 6 months
Systemic glucocorticoids e.g. prednisone 20 mg daily or equivalent doses of other glucocorticoids for more than two weeks in the past 6 months
Baseline hematocrit >48%
PSA >4 ng/ml in Caucasians; >3 ng/ml in African-Americans
Men with 1st order relatives with a history of prostate cancer
Uncontrolled congestive heart failure
Severe untreated sleep apnea
Myocardial infarction, acute coronary syndrome, revascularization surgery, or stroke within 3 months
o Previous stroke with residual cognitive or functional deficits; Mini-Mental State Examination score <24
Serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
Poorly controlled diabetes as defined by hemoglobin A1c >8.5%; Body mass index (BMI) >45 kg/m2
Untreated unipolar depression (treated depression with medications or counseling will be allowed
Bipolar disorder or schizophrenia
Primary purpose
Allocation
Interventional model
Masking
240 participants in 2 patient groups, including a placebo group
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Central trial contact
Jose M Garcia, MD, PhD
Data sourced from clinicaltrials.gov
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