Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Cedars-Sinai Medical Center

Status: Completed

Conditions: Cancer

Treatments: Other: Cardiac Aggressive Risk MitigAtion Plan

Study type: Interventional

Funder types: Other

Identifiers

NCT05403736

IIT2021-07-Atkins-CARMA

Details and patient eligibility

About

The purpose of this study is to examine adherence to cardio-oncology consultation.

Full description

The purpose of this study is to evaluate patient participation in a plan to improve heart health after radiation therapy by having a cardio-oncology assessment early during cancer treatment. Cardiologists and cancer doctors will review any cardiovascular risk factors (heart conditions, hypertension, bleeding disorders, smoking history, obesity, cholesterol and diabetes) and develop a personalized treatment plan. In addition, the study will evaluate use of wearable devices such as a FitBit, and remote EKG (Omron EVOLV) and blood pressure monitoring (AliveCor KardiaMobile) devices to monitor participant's health. Blood will be drawn at three separate timepoints for biomarker testing of heart injury, aging, inflammation and metabolism.

Study visits will occur at baseline, weekly during radiation therapy, 6 weeks and 3 months after completion of radiation therapy.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field.
• Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
• Planning to receive standard of care radiotherapy treatments.
• Access to a smart device that has the capability to sync to the devices.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
• Ability to read, write and understand English.

Exclusion criteria

• Known allergy to surgical steel or elastomer/rubber.
• Heart attack within 6 months prior to study enrollment.
• Severe and/or active scleroderma or systemic lupus erythematosus.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CARMA

Experimental group

Description:

Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Treatment:

Other: Cardiac Aggressive Risk MitigAtion Plan