NCT04301765 Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
| NCT ID | NCT04301765 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seattle Institute for Biomedical and Clinical Research |
| Condition | Hypogonadism, Male |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2021-01-12 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 230 participants in total. It began in 2021-01-12 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a large randomized, double-blind, placebo-controlled trial to determine the efficacy of testosterone replacement on cancer-related fatigue in older men with solid or hematologic (blood) cancer who report fatigue and have low testosterone levels.
Eligibility Criteria
Inclusion Criteria: * Men with active solid or hematologic (blood) cancers who have received or are receiving chemo- and/or radiation therapy. Patients who have no evidence of disease (NED) for 60 months or less, which means that they are \<60 months from their last treatment (chemotherapy and/or radiation therapy) will be included. * Age: 55 years and older * Life expectancy of at least 6 months. * 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 men is 348 ng/dL and the lower limits of free testosterone is \<70 pg/ml in the Framingham Heart Study sample. 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, but their free testosterone levels may still be below the lower limit of normal. Thus, men with free testosterone \<70 pg/mL will be included. * Fatigue. Fatigue was selected as it is a highly prevalent symptom in cancer patients. Fatigue will be defined as a score on FACIT-Fatigue subscale of \<40, which best divides cancer patients from the general population with accuracy. * Ability and willingness to provide informed consent Exclusion Criteria: * Men with current or prior history of prostate, breast, testicular, or adrenal cancers. * Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months * Hematocrit \>48%, serum creatinine \>2.5 mg/dL * PSA \>4 ng/ml; nodule or induration on digital rectal exam * Severe untreated sleep apnea * Uncontrolled congestive heart failure * Myocardial infarction, acute coronary syndrome, revascularization surgery, stroke or thromboembolism (of any etiology) within 6 months * Known history of thrombophilia due to a genetic mutation (e.g. Factor V Leiden) * Previous stroke with residual cognitive or functional deficits * Inability to provide informed consent; MMSE score \<24 * Poorly controlled diabetes as defined by hemoglobin A1c \>10.0% * Body mass index (BMI) \>40 kg/m2 * Bipolar disorder or schizophrenia
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04301765 clinical trial?
This trial is open to male participants only, aged 55 Years or older, studying Hypogonadism, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04301765 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04301765 currently recruiting?
Yes, NCT04301765 is actively recruiting participants. Contact the research team at jg77@uw.edu for enrollment information.
Where is the NCT04301765 trial being conducted?
This trial is being conducted at Augusta, United States, Boston, United States, Seattle, United States.
Who is sponsoring the NCT04301765 clinical trial?
NCT04301765 is sponsored by Seattle Institute for Biomedical and Clinical Research. The trial plans to enroll 230 participants.