Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

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.

Conditions

Hypogonadism, Male, Fatigue Syndrome, Chronic

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Study Overview

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Study Details

Study overview

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.

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

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Condition
Hypogonadism, Male
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Seattle

Veterans Affairs Puget Sound Health Care System, Seattle, Washington, United States, 98108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * 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

Ages Eligible for Study

18 Years to 54 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Seattle Institute for Biomedical and Clinical Research,

Jose M Garcia, MD, PhD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System

Study Record Dates

2026-01-30