Status:
RECRUITING
Testosterone Replacement in Male Cancer Survivors With Fatigue and Low Testosterone
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Conditions:
Hypogonadism, Male
Fatigue Syndrome, Chronic
Eligibility:
MALE
18-54 years
Phase:
PHASE2
Brief Summary
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, qua...
Detailed Description
The overall goal of this proposal is to evaluate the efficacy of testosterone replacement therapy in improving fatigue and other outcomes such as sexual function, quality of life, body composition, mu...
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
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04049331
Start Date
March 22 2021
End Date
January 30 2027
Last Update
March 11 2025
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108