Testosterone shot may ease fatigue in young cancer survivors
NCT ID NCT04049331
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a testosterone drug (Depo-Testosterone) can reduce fatigue and improve sexual function, mood, and body composition in young men (ages 18-54) who have survived cancer and now have low testosterone. Participants must be in remission for at least one year and report ongoing fatigue. The study compares testosterone injections to a placebo over several months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 54 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham and Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Veterans Affairs Puget Sound Health Care System
RECRUITINGSeattle, Washington, 98108, United States
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