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

Part of paid clinical trials in Augusta, Georgia.

Sponsor
Seattle Institute for Biomedical and Clinical Research
Study ID
NCT04301765
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Cancer
  • Fatigue
  • Hypogonadism, Male

Eligibility Criteria

Sex
MALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • testosterone 1.62% gel — DRUG
    The 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 gel — OTHER
    The 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

Study Details

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.

Key Dates

Start date
Jan 12, 2021
Status verified
Mar 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Fatigue change [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912
Egidio Del Fabbro, MD
Brigham and Women's HospitalBostonMassachusetts02115
Milena Braga, MD
[email protected]
617-525-9144
Shehzad Basaria, MD (PRINCIPAL_INVESTIGATOR)
Veterans Affairs Puget Sound Health Care SystemSeattleWashington98108
Haley Lowe, RN, MN
[email protected]
2062774253
Lindsey Anderson, PhD
[email protected]
2062776719
Jose M Garcia, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Augusta, GA

By research site
Georgia Cancer Center at Augusta University· Augusta, GABrigham and Women's Hospital· Boston, MAVeterans Affairs Puget Sound Health Care System· Seattle, WA

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