Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

NCT05403736 | Completed DMC

• 1 other identifier: IIT2021-07-Atkins-CARMA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

radiation therapy; cardio-oncology; cardiology; cardiac toxicity; lung cancer; esophageal cancer; breast cancer; thoracic radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of participants who complete the cardio-oncology consultation visit

  Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.

  From baseline to 3 months

Secondary Outcomes (6)

• Number of participants who wear the FitBit device at least 10 hours per day for 4 out of the 7 days prior to each study visit

  From baseline to 3 months

• Number of participants who obtain blood pressure readings for at least 4 timepoints

  From baseline to 3 months

• Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints

  From baseline to 3 months

• Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist

  From baseline to 3 months

• Rate of compliance with cardiovascular therapeutic medication intervention

  From baseline to 3 months

Study Arms (1)

CARMA

EXPERIMENTAL

Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Other: Cardiac Aggressive Risk MitigAtion Plan

Interventions

Cardiac Aggressive Risk MitigAtion Plan 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.

Also known as: FitBit, Omron EVOLV Automatic Blood Pressure Monitor, AliveCor KardiaMobile Personal EKG Monitor, cardio-oncology consultation

CARMA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cancer Clinical Trials Office

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Neoplasms; Cardiotoxicity; Lung Neoplasms; Esophageal Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Katelyn Atkins, MD, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Model Details: Open Label

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: June 3, 2022
• Study Start: October 7, 2022
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)