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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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of testosterone replacement therapy on cancer-related fatigue, sexual dysfunction, and quality of life in men aged 55 years and older who have solid or blood cancers and low testosterone levels. This large randomized, double-blind, placebo-controlled trial aims to determine if 6 months of testosterone gel application can improve these symptoms in men who report fatigue and have testosterone deficiency. Participants will be randomly assigned to receive either testosterone 1.62% gel or a placebo gel, both applied daily at home for 6 months. All participants will receive training and printed instructions on how to apply the gel. The study includes five visits: screening, baseline, a 2-week dose adjustment, a 3-month visit, and a 6-month visit. During the study, participants will be monitored for changes in fatigue and sexual activity scores over 6 months. Researchers will conduct assessments at each visit, including blood tests to measure testosterone levels and other health markers. The trial also tracks body composition and muscle function, ensuring participant safety and treatment adherence throughout the study period.
CONDITIONS
Brief 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 blood cancers who have received or are receiving chemotherapy or radiation therapy and are within 60 months of their last treatment
- Age 55 years and older
- Life expectancy of at least 6 months
- Low serum testosterone (<348 ng/dl) or low free testosterone (<70 pg/ml) measured by mass spectrometry
- Fatigue defined as a FACIT-Fatigue subscale score less than 40
- Ability and willingness to provide informed consent
You will not qualify if you...
- History of prostate, breast, testicular, or adrenal cancers
- Use of anabolic agents such as testosterone, DHEA, or growth hormone within the past 6 months
- Hematocrit greater than 48% or serum creatinine over 2.5 mg/dL
- PSA over 4 ng/ml or abnormal digital rectal exam findings
- Severe untreated sleep apnea
- Uncontrolled congestive heart failure
- Recent heart attack, stroke, or thromboembolism within 6 months
- Known genetic thrombophilia
- Previous stroke with lasting cognitive or functional deficits
- Inability to provide informed consent or MMSE score less than 24
- Poorly controlled diabetes with hemoglobin A1c over 10.0%
- Body mass index over 40 kg/m2
- Diagnosis of bipolar disorder or schizophrenia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks
Participants learn how to apply the testosterone or placebo gel daily at home and start baseline assessments.
1 baseline visit
Duration - 6 months
Participants apply testosterone or placebo gel daily at home for 6 months to assess effects on fatigue, sexual function, body composition, and muscle function.
4 visits (Baseline, 2-week dose adjustment, 3-month, and 6-month visits)
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
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3
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108
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Research Team
J
Jose Garcia, MD, Phd
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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