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NCT05637216 · ClinicalTrials.gov registry record · Phase 2
Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients
A Phase 2 study of Radiation Induced Fibrosis, sponsored by Shaw Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05637216: Recruiting Phase 2 study of Radiation Induced Fibrosis, sponsored by Shaw Cancer Center.
NCT05637216 is a Phase 2 study of Radiation Induced Fibrosis that is actively recruiting participants, run by Shaw Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05637216, a Phase 2 study of Radiation Induced Fibrosis, is actively recruiting participants, sponsored by Shaw Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate the efficacy of losartan (LOS), an FDA-approved transforming growth factor beta-1 (TGF-β1) blocker, to decrease radiation induced fibrosis (RIF) in the breast and the lung of breast cancer patients, testing the hypothesis that Losartan will decrease RIF, TGF- β1 and cellular senescence/inflammation in the breast and the lung of irradiated breast cancer patients relative to placebo treatment and consequently improve clinical outcomes in breast cancer patients.
Primary Outcome
Fibrosis will be assessed by a radiation oncology provider using the Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) (LENT-SOMA) scale. 0=Fibrosis absent, not detectable. 1=Fibrosis is Barely Palpable; 2=Definite increased density; 3=Very marked density, retraction and firmness and fixation
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Losartan 25 milligram capsule
Study Locations (1)
Colorado
- Vail Health Shaw Cancer Center - Edwards
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2027-08-17 |
| Phase | Phase 2 |
What NCT05637216 shows while recruiting
NCT05637216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Radiation Induced Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05637216 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05637216 about?
NCT05637216 is a clinical study titled "Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients". This study will evaluate the efficacy of losartan (LOS), an FDA-approved transforming growth factor beta-1 (TGF-β1) blocker, to decrease radiation induced fibrosis (RIF) in the breast and the lung of breast cancer patients, testing the hypothesis that Losartan will decrease RIF, TGF- β1 and cellular...
What is the current status of trial NCT05637216?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-08-17. Estimated completion is 2027-08-17.
What conditions does trial NCT05637216 study?
This clinical trial studies the following conditions: Radiation Induced Fibrosis.
What interventions are being tested in trial NCT05637216?
The interventions under investigation include: Placebo (DRUG), Losartan 25 milligram capsule (DRUG).
Who is sponsoring clinical trial NCT05637216?
This trial is sponsored by Shaw Cancer Center, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05637216 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05637216's enrollment target sits among peer trials
40 1362nd of 2000 higher than 543 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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