Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

NCT ID: NCT05403736

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-07

Study Completion Date

2023-06-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Label
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CARMA

Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Group Type EXPERIMENTAL

Cardiac Aggressive Risk MitigAtion Plan

Intervention Type OTHER

Cardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices.

Interventions

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Cardiac Aggressive Risk MitigAtion Plan

Cardio-oncology consultation along with long-term collaborative cancer care visits during standard of care radiation therapy that will occur weekly for up to 6 weeks followed by 6-week and 3-month follow-up visits. Health will be monitored with biosensor monitoring devices.

Intervention Type OTHER

Other Intervention Names

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FitBit Omron EVOLV Automatic Blood Pressure Monitor AliveCor KardiaMobile Personal EKG Monitor cardio-oncology consultation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Katelyn Atkins

Assistant Professor, Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katelyn Atkins, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cancer Clinical Trials Office

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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IIT2021-07-Atkins-CARMA

Identifier Type: -

Identifier Source: org_study_id

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