Improving Patient-Important Outcomes with Testosterone Replacement in Hypogonadal Men with a Prior History of Cancer

Protocol # :
Hypogonadism, Male
Fatigue Syndrome, Chronic
Disease Sites
Gastroesophageal Junction
Lip, Oral Cavity and Pharynx
Small Intestine
Other Digestive Organ
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Corpus Uteri
Other Female Genital
Other Male Genital
Urinary Bladder
Other Urinary
Eye and Orbit
Brain and Nervous System
Other Hematopoietic
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Multiple Myeloma
Lymphoid Leukemia
Myeloid and Monocytic Leukemia
Leukemia, other
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Basaria, Shehzad

Trial Description

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.

Eligibility Requirements

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.
Therefore, young symptomatic men with total testosterone <348 ng/dl could be
considered testosterone deficient. 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. However; their free testosterone levels may
still be below the lower limit of normal. Thus, we will also include men with free
testosterone <70 pg/mL.

- Self-reported fatigue. We have selected these symptoms because they are commonly
reported in male cancer survivors. Fatigue will be defined as a score on Functional
Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale of <40, which best
divides cancer patients from the general population with 84% accuracy, and was used as
the cut-off for the NIA-funded 50-million-dollar testosterone trial (The T-Trial).

- Ability and willingness to provide informed consent.

Exclusion Criteria:

- Men with hormone-dependent cancers (breast, prostate or adenocarcinoma of unknown

- 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; nodule/induration on
digital rectal exam

- 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