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Losartan for Radiation-Induced Heart Failure in Breast Cancer

Q: Is this medical research currently open to new participants?

<p>The information posted on clinicaltrials.gov indicates this medical trial is not admitting new patients at the present moment. The study was first announced on January 1st 2023, and underwent its most recent edit November 1st 2022; thus, it has been closed to enrollment for some time now. There are still 2494 other active trials that need participants currently though.</p>

Phase < 1

Recruiting

Led By Rachel Jimenez, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Non-metastatic Breast Cancer patients scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)

Patients must have Left-sided Breast Cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial looks at if losartan can reduce risk of radiation-induced heart failure in breast cancer patients receiving radiation therapy.

Who is the study for?

This trial is for adults over 18 with non-metastatic left-sided breast cancer scheduled for radiation therapy, including internal mammary lymph nodes. They must be able to consent and have no MRI contraindications. Excluded are pregnant or breastfeeding individuals, those allergic to Losartan biosimilars, unable to swallow pills, or already on ACE/ARBs.Check my eligibility

What is being tested?

The study tests if Losartan can prevent heart failure caused by radiation in breast cancer treatment. Participants will receive standard radiation therapy and either Losartan or a placebo to compare outcomes.See study design

What are the potential side effects?

Losartan may cause dizziness due to low blood pressure, kidney function changes, high potassium levels, and rare allergic reactions. Radiation therapy might lead to skin irritation at the site of treatment and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have breast cancer that hasn't spread and will receive radiation therapy to the left side, including lymph nodes.

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My breast cancer is in the left breast.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Extracellular Volume (ECV) of Myocardial Fibrosis

Secondary outcome measures

Serum cardiac biomarker

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation Therapy and LosartanExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,471 Total Patients Enrolled

80 Trials studying Breast Cancer

132,902 Patients Enrolled for Breast Cancer

Rachel Jimenez, MDPrincipal InvestigatorMassachusetts General Hospital

3 Previous Clinical Trials

180 Total Patients Enrolled

1 Trials studying Breast Cancer

60 Patients Enrolled for Breast Cancer

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT05607017 — Phase < 1

Breast Cancer Research Study Groups: Radiation Therapy and Losartan

Breast Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT05607017 — Phase < 1

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607017 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical research currently open to new participants?

"The information posted on clinicaltrials.gov indicates this medical trial is not admitting new patients at the present moment. The study was first announced on January 1st 2023, and underwent its most recent edit November 1st 2022; thus, it has been closed to enrollment for some time now. There are still 2494 other active trials that need participants currently though."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Losartan in Prevention of Radiation-Induced Heart Failure

Rachel Beth Jimenez 2024. "Losartan in Prevention of Radiation-Induced Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05607017.