Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men with Cancer and Androgen Deficiency

Who is this study for? Males with Hypogonadism, Cancer, Fatigue
What treatments are being studied? Testosterone Gel
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Georgia Cancer Center at Augusta University
RECRUITING
Augusta
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Washington
Veterans Affairs Puget Sound Health Care System
RECRUITING
Seattle
Contact Information
Primary
Jose Garcia, MD, Phd
jg77@uw.edu
206 764 2984
Time Frame
Start Date: 2021-01-12
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 230
Treatments
Experimental: testosterone 1.62% gel
Testosterone 1.62% gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.
Placebo_comparator: placebo gel
The placebo gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months.
Authors
Jose M Garcia, Shehzad Basaria
Sponsors
Leads: Seattle Institute for Biomedical and Clinical Research

This content was sourced from clinicaltrials.gov

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