Status:
RECRUITING
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
Lead Sponsor:
Seattle Institute for Biomedical and Clinical Research
Conditions:
Hypogonadism, Male
Cancer
Eligibility:
MALE
55+ years
Phase:
PHASE2
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...
Detailed Description
The overall objective is to conduct a double-blind, randomized, placebo-controlled, parallel group trial to determine the efficacy of 6 months of physiological testosterone replacement therapy in impr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT04301765
Start Date
January 12 2021
End Date
January 31 2026
Last Update
March 11 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108