Losartan in Prevention of Radiation-Induced Heart Failure

NCT ID: NCT05607017

Last Updated: 2024-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2024-12-01

Brief Summary

This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer.

The interventions involved in this study are:

• Losartan
• Radiation Therapy (standard of care)

Detailed Description

This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy.

Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer.

The FDA has approved radiation therapy as a treatment option for breast cancer.

The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year.

It is expected that about 10 people will take part in this research study.

Conditions

Breast Cancer; Myocardial Fibrosis; Radiation-Induced Fibrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation Therapy and Losartan

Participants will receive radiation therapy 5x weekly over 1-6 weeks. Participants will receive Losartan 1x daily during radiation therapy and for up to 6 months afterward then be followed for 1 year

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

Taken Orally

Radiation Therapy

Intervention Type: RADIATION

Photon Radiation Therapy

Interventions

Losartan

Taken Orally

Intervention Type: DRUG

Radiation Therapy

Photon Radiation Therapy

Intervention Type: RADIATION

Other Intervention Names

Losartan Potassium

Eligibility Criteria

Inclusion Criteria

->18 years of age

• Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
• Prior chemotherapy is permitted
• Patients must have Left-sided Breast Cancer
• Ability to understand and the willingness to sign a written informed consent document
• No contraindication to MRI

Exclusion Criteria

• Person who is pregnant or breastfeeding.
• Patient unable to swallow oral medication.
• Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity
• Patients already receiving ACE/ARBs.
• Patients with a history of allergic reactions to Losartan biosimilars.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Rachel Beth Jimenez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Jimenez, MD

Role: CONTACT

rbjimenez@partners.org

617-726-8651

Facility Contacts

Rachel Jimenez, MD

Role: primary

RBJIMENEZ@PARTNERS.ORG

617-726-8651

Other Identifiers

22-457

Identifier Type: -

Identifier Source: org_study_id