Clinical trial
The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure
Name
22-457
Description
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)
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-10-01
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Losartan
Taken Orally
Arms:
Radiation Therapy and Losartan
Other names:
Losartan Potassium
Radiation Therapy
Photon Radiation Therapy
Arms:
Radiation Therapy and Losartan
Size
10
Primary endpoint
Extracellular Volume (ECV) of Myocardial Fibrosis
6 months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2024-01-12
1 organization
1 drug
3 indications
Organization
Massachusetts General HospitalDrug
LosartanIndication
Breast CancerIndication
Cardiac FibrosisIndication
Radiation-induced fibrosis