RECRUITING

Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pilot Study of Losartan to Reduce Radiation Induced Fibrosis in Breast Cancer Patients

Quick Facts

Study Start:2023-08-17
Study Completion:2027-08-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05637216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Katie Hess, BS
CONTACT
(970) 485-7874
katherine.hess@vailhealth.org
Paige Bordelon, MPH
CONTACT
(970) 569-7806
paige.bordelon@vailhealth.org

Principal Investigator

Patricia H Hardenbergh, MD
PRINCIPAL_INVESTIGATOR
Vail Health Shaw Cancer Center

Study Locations (Sites)

Vail Health Shaw Cancer Center
Edwards, Colorado, 81632
United States

Collaborators and Investigators

Sponsor: Shaw Cancer Center

  • Patricia H Hardenbergh, MD, PRINCIPAL_INVESTIGATOR, Vail Health Shaw Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-17
Study Completion Date2027-08-17

Study Record Updates

Study Start Date2023-08-17
Study Completion Date2027-08-17

Terms related to this study

Keywords Provided by Researchers

  • losartan
  • radiation
  • fibrosis
  • cosmesis
  • reoperation
  • TGFB1
  • Transforming growth factor beta 1 (TGF-β1)
  • Angiotensin II Receptor Blockers
  • ace inhibitor
  • Angiotensin-converting enzyme (ACE) inhibitors
  • TGF-β1
  • antifibrotic
  • signaling pathway
  • breast cancer
  • TGF beta
  • radiation induced fibrosis
  • irradiation fibrosis
  • Radiation injury with fibrosis
  • Transforming growth factor beta 1
  • Inflammation
  • Biomarker
  • Suppressor of Mothers against Decapentaplegic (SMAD)

Additional Relevant MeSH Terms

  • Radiation Induced Fibrosis