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NCT04301765 · ClinicalTrials.gov registry record · Phase 2
Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency
A Phase 2 study of Cancer and Fatigue, sponsored by Seattle Institute for Biomedical and Clinical Research.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 230
- Enrollment target
- 3
- Study locations
NCT04301765: Recruiting Phase 2 study of Cancer and Fatigue, sponsored by Seattle Institute for Biomedical and Clinical Research.
NCT04301765 is a Phase 2 study of Cancer and Fatigue that is actively recruiting participants, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 230 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04301765, a Phase 2 study of Cancer and Fatigue, is actively recruiting participants, sponsored by Seattle Institute for Biomedical and Clinical Research.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 230 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Primary outcome is change in fatigue score. Fatigue will be assessed by the Functional Assessment of Chronic Illness Therapy fatigue scale (FACIT-Fatigue)- The FACIT-Fatigue has been widely used in studies related to cancer-related fatigue and is able to detect clinically meaningful differences in fatigue scores in response to treatment. Population norms for the FACIT are also available, facilitating the interpretation of fatigue levels in patient populations. This instrument has been well-valid
Conditions Studied
Interventions
- DRUG testosterone 1.62% gel
- OTHER placebo gel
Study Locations (3)
Georgia
- Georgia Cancer Center at Augusta University - Augusta
Massachusetts
- Brigham and Women's Hospital - Boston
Washington
- Veterans Affairs Puget Sound Health Care System - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2021-01-12 |
| Est. Completion | 2026-01-31 |
| Phase | Phase 2 |
What NCT04301765 shows while recruiting
NCT04301765 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Cancer appearing as the primary indexed condition, and to 2 interventions - of which testosterone 1.62% gel is the first listed.
NCT04301765 reports a single indexed study location in Georgia, Massachusetts, Washington.
Frequently Asked Questions
What is clinical trial NCT04301765 about?
NCT04301765 is a clinical study titled "Improving Cancer-related Fatigue, Sexual Dysfunction and Quality of Life in Older Men With Cancer and Androgen Deficiency". 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.
What is the current status of trial NCT04301765?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 230 participants. The study started on 2021-01-12. Estimated completion is 2026-01-31.
What conditions does trial NCT04301765 study?
This clinical trial studies the following conditions: Cancer, Fatigue, Hypogonadism, Male.
What interventions are being tested in trial NCT04301765?
The interventions under investigation include: testosterone 1.62% gel (DRUG), placebo gel (OTHER).
Who is sponsoring clinical trial NCT04301765?
This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04301765 being conducted?
This trial has 3 study locations across Georgia, Massachusetts, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04301765's enrollment target sits among peer trials
230 220th of 615 higher than 396 of 615 other Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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