Clinical Trials

Trial Description:
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 incurable cancer who report fatigue and have low testosterone levels.

Eligibility Requirements:
- Men with active lung or colorectal cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are <60 months from their last treatment (chemotherapy and/or radiation therapy) will be included.
- Age: 55 years and older
- Life expectancy of at least 6 months.
- 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 men is 348 ng/dL and the lower limits of free testosterone is <70 pg/ml in the Framingham Heart Study sample. As sex hormone binding globulin levels may be elevated in some men with cancer (resulting in elevation in total testosterone level), some of these symptomatic men may still be hypogonadal despite having total testosterone above this cut-off limit, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone <70 pg/mL will be included.
- Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of <40, which best divides cancer patients from the general population with accuracy.
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Men with current or prior history of hormone-dependent cancers (breast, prostate)
- Men with brain metastases from any type of cancer
- Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
- Current use of systemic glucocorticoids (unless part of the chemotherapy regimen)
- Appetite stimulating agents (e.g. megestrol acetate) within the past 1 month
- Hematocrit >48%, serum creatinine >2.5 mg/dL; ALT 3x upper limit of normal
- PSA >4 ng/ml; nodule or induration on digital rectal exam
- Severe untreated sleep apnea
- Uncontrolled congestive heart failure
- Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months
- Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden)
- Previous stroke with residual cognitive or functional deficits
- Inability to provide informed consent; MMSE score <24
- Poorly controlled diabetes as defined by hemoglobin A1c >8.5%
- Body mass index (BMI) >40 kg/m2
- Untreated unipolar depression (treated depression is allowed)
- Bipolar disorder or schizophrenia

Protocol #: 20-183