Actively Recruiting
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Led by Seattle Institute for Biomedical and Clinical Research · Updated on 2026-03-31
230
Participants Needed
3
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men with active solid or hematologic (blood) cancers who have received or are receiving chemotherapy and/or radiation therapy, or have no evidence of disease for 60 months or less since last treatment
- Age 55 years or older
- Life expectancy of at least 6 months
- Serum testosterone below 348 ng/dL and/or free testosterone below 70 pg/mL
- Fatigue defined by a FACIT-Fatigue subscale score below 40
- Ability and willingness to provide informed consent
You will not qualify if you...
- History or current diagnosis of prostate, breast, testicular, or adrenal cancers
- Use of anabolic agents (testosterone, DHEA, growth hormone) within the past 6 months
- Hematocrit above 48% or serum creatinine above 2.5 mg/dL
- PSA above 4 ng/mL or abnormal digital rectal exam findings
- Severe untreated sleep apnea
- Uncontrolled congestive heart failure
- Recent myocardial infarction, acute coronary syndrome, revascularization surgery, stroke, or thromboembolism within 6 months
- Known genetic thrombophilia
- Previous stroke with residual cognitive or functional deficits
- Inability to provide informed consent or MMSE score below 24
- Poorly controlled diabetes with hemoglobin A1c above 10.0%
- Body mass index greater than 40 kg/m2
- Bipolar disorder or schizophrenia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108
Actively Recruiting
Research Team
J
Jose Garcia, MD, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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