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Testosterone Replacement for Fatigue in Male Cancer Survivors

This study is testing if a testosterone drug called Testosterone Undecanoate (AVEED) can help young male cancer survivors who are experiencing fatigue and have low testosterone levels. Researchers want to see if this drug improves fatigue, sexual function, quality of life, body composition (the amount of fat and muscle in your body), muscle strength, and physical activity. You might be able to join if you are a male cancer survivor between 18 and 54 years old, have been in remission for at least one year from a non-hormone-dependent cancer, and have low testosterone. The main goal is to see how much fatigue changes over 9 months.

Study design
This study is a randomized, placebo-controlled trial, meaning some participants will receive the active drug and others will receive an inactive substance (placebo). It plans to enroll 240 men.
What's involved
Participants will receive five doses of either Testosterone Undecanoate or placebo. The first two doses are four weeks apart, and the next three doses are every ten weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring fatigue change is at 9 months after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04049331

Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone

Recruiting
PHASE2Ages 18–54InterventionalTreatment
Seattle Institute for Biomedical and Clinical Research
~240 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fatigue change
Measured over 9 months

Conditions

Hypogonadism, Male
Fatigue Syndrome, Chronic

Explore related trials

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NCT04049331

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Veterans Affairs Puget Sound Health Care System

    Seattle, Washingtonstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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

Who to contact

Jose M Garcia, MD, PhD
[email protected]
206 764 2984
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Fatigue change9 months

    (Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) questionnaire