Testosterone treatment for fatigue in male cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of testosterone replacement therapy using Depo-Testosterone in young male cancer survivors who experience fatigue and have low testosterone levels. It is a double-blind, randomized, placebo-controlled trial aimed at assessing improvements in fatigue, sexual function, quality of life, body composition, muscle strength, and physical activity. Participants must be in remission for at least one year after receiving chemotherapy or radiation therapy. The study hypothesizes that testosterone administration will lead to greater improvements in fatigue scores compared to a placebo.

Why it matters

Who can join: the full rules

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 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

Where it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting
• Veterans Affairs Puget Sound Health Care System
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Jose M Garcia, MD, PhD — VA Puget Sound Health Care System
• Study coordinator: Jose M Garcia, MD, PhD
• Email: jg77@uw.edu
• Phone: 206 764 2984

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.