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Trial Title:
Losartan in Prevention of Radiation-Induced Heart Failure
NCT ID:
NCT05607017
Condition:
Breast Cancer
Myocardial Fibrosis
Radiation-Induced Fibrosis
Conditions: Official terms:
Heart Failure
Fibrosis
Radiation Fibrosis Syndrome
Losartan
Conditions: Keywords:
Breast Cancer
Myocardial Fibrosis
Radiation-Induced Fibrosis
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Losartan
Description:
Taken Orally
Arm group label:
Radiation Therapy and Losartan
Other name:
Losartan Potassium
Intervention type:
Radiation
Intervention name:
Radiation Therapy
Description:
Photon Radiation Therapy
Arm group label:
Radiation Therapy and Losartan
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Jimenez, MD
Phone:
617-726-8651
Email:
RBJIMENEZ@PARTNERS.ORG
Investigator:
Last name:
Rachel Jimenez, MD
Email:
Principal Investigator
Start date:
January 1, 2024
Completion date:
December 1, 2024
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05607017
