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Completed

NCT Number: NCT05403736

Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Clinical Trials Office

Los Angeles, California, 90048, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: FitBit, Omron EVOLV Automatic Blood Pressure Monitor, AliveCor KardiaMobile Personal EKG Monitor, cardio-oncology consultation

Primary outcomes

  1. Number of participants who complete the cardio-oncology consultation visit

    Time frame: From baseline to 3 months

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

Secondary outcomes

  1. 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

    Time frame: From baseline to 3 months

    Proportion 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

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

    Time frame: From baseline to 3 months

    Proportion of participants who obtain blood pressure readings for at least 4 timepoints.

    -The Omron blood pressure monitor will be used to obtain blood pressure readings.

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

    Time frame: From baseline to 3 months

    Proportion of participants who obtain EKG readings for at least 4 timepoints.

    -The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings

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

    Time frame: From baseline to 3 months

    Number of participants provided recommendation to either initiate, or modify the dose of, a cardiovascular risk-reducing medication (anti-lipid, anti-platelet, anti-coagulation, anti-hypertensive). Expressed as the number of participants as a fraction of the total number of participants.

  5. Rate of compliance with cardiovascular therapeutic medication intervention

    Time frame: From baseline to 3 months

    Compliance will be assessed by self-reporting of medication usage at the 3-month follow-up and defined as yes or no for all recommended cardiovascular therapeutic medication interventions. Expressed as the number of participants as a fraction of the total number of participants.

  6. Evaluate participant intervention perspectives at the end of the study.

    Time frame: At 3 months

    • Analyze participate attitudes and perspectives on implementation and impact of the cardiovascular intervention plan. Participants will be asked to complete a survey at the 3-month visit.
    • Each question is either answered on a scale of 1-4 or strongly agree-strongly disagree, where higher scores indicate the highest level of burden or disagreement, respectively.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

Acronym: CARMA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2022
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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