MTG201-MPM-001Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men with Cancer and Androgen Deficiency

Protocol # :
Hypogonadism, Male
Disease Sites
Principal Investigator
Basaria, Shehzad

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 solid or hematologic
(blood) cancer who report fatigue and have low testosterone levels.

Eligibility Requirements

Inclusion Criteria:

- 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.

- 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 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

- 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 >10.0%

- Body mass index (BMI) >40 kg/m2

- Bipolar disorder or schizophrenia