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Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial (CARMA)

Primary Purpose

Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Aggressive Risk MitigAtion Plan
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring radiation therapy, cardio-oncology, cardiology, cardiac toxicity, lung cancer, esophageal cancer, breast cancer, thoracic radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cancer Clinical Trials Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CARMA

Arm Description

Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Number of participants who obtain blood pressure readings for at least 4 timepoints
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.
Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints
Proportion of participants who obtain EKG readings for at least 4 timepoints. -The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings
Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist
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.
Rate of compliance with cardiovascular therapeutic medication intervention
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.
Evaluate participant intervention perspectives at the end of the study.
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.

Full Information

First Posted
March 11, 2022
Last Updated
October 3, 2023
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05403736
Brief Title
Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
Acronym
CARMA
Official Title
IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 7, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
radiation therapy, cardio-oncology, cardiology, cardiac toxicity, lung cancer, esophageal cancer, breast cancer, thoracic radiotherapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open Label
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARMA
Arm Type
Experimental
Arm Description
Cardiac Aggressive Risk MitigAtion plan with biosensor monitoring
Intervention Type
Other
Intervention Name(s)
Cardiac Aggressive Risk MitigAtion Plan
Other Intervention Name(s)
FitBit, Omron EVOLV Automatic Blood Pressure Monitor, AliveCor KardiaMobile Personal EKG Monitor, cardio-oncology consultation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants who complete the cardio-oncology consultation visit
Description
Adherence is defined as 70% of the participants completing the cardio-oncology consultation visit prior to or during radiotherapy.
Time Frame
From baseline to 3 months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
From baseline to 3 months
Title
Number of participants who obtain blood pressure readings for at least 4 timepoints
Description
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.
Time Frame
From baseline to 3 months
Title
Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints
Description
Proportion of participants who obtain EKG readings for at least 4 timepoints. -The AliveCor KardiaMobile EKG monitor will be used to obtain EKG readings
Time Frame
From baseline to 3 months
Title
Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist
Description
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.
Time Frame
From baseline to 3 months
Title
Rate of compliance with cardiovascular therapeutic medication intervention
Description
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.
Time Frame
From baseline to 3 months
Title
Evaluate participant intervention perspectives at the end of the study.
Description
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.
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katelyn Atkins, MD, PhD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Clinical Trials Office
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States

12. IPD Sharing Statement

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Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial

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