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.
Men with active solid or hematologic (blood) 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.
Men with current or prior history of prostate, breast, testicular, or adrenal cancers.
Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
Hematocrit >48%, serum creatinine >2.5 mg/dL
PSA >4 ng/ml; nodule or induration on digital rectal exam
Parallel
testosterone 1.62% gel
DrugThe gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months
placebo gel
Other interventionThe gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months
Fatigue change
Primary outcome is change in fatigue score. Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-Fatigue)- The FACIT-Fatigue has been widely used in studies related to cancer-related fatigue and is able to detect clinically meaningful differences in fatigue scores in response to treatment. Population norms for the FACIT are also available, facilitating the interpretation of fatigue levels in patient populations. This instrument has been well-validated, is responsive to treatment and more sensitive to change in fatigue than other instruments. Score range: 0-52, the higher the score the better quality of life.
Change in Sexual Activity Score
Secondary outcome is change in sexual activity score, assessed by the Harbor-UCLA 7-day Sexual Function Questionnaire.
Change in Other Measures of Sexual Function
Erectile function will be assessed by International Index of Erective Function (IIEF).
Change in Mood and Well-being
Mood and well-being will be assessed by Positive and Negative Affect Scale (PANAS), which includes 10 questions each for Positive Affect and Negative Affect. Many behavioral scientists consider affectivity as the cleanest window on an individual's wellbeing. The most sensitive indicator of impaired wellbeing has been shown to be affective dysregulation, which is reflected in affectivity balance. The latter incorporates negative affects (e.g., anxiety, depression) as well as positive affects (e.g., joy).
Body Composition Changes
Body composition changes will be assessed by measuring lean body mass and fat mass by dual energy X-ray absorptiometry (DEXA).
Muscle Strength Changes
Muscle strength will be assessed by measuring maximal voluntary strength in the leg press exercise by the 1-RM method.
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