Clinical trial NCT05403736: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
Official title: IIT2021-07-Atkins-CARMA: Cardiac Aggressive Risk Mitigation in Thoracic Radiotherapy (CARMA) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: radiation therapy
cardio-oncology
cardiology
cardiac toxicity
lung cancer
esophageal cancer
breast cancer
thoracic radiotherapy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Number of participants who complete the cardio-oncology consultation visit
timeFrame: From baseline to 3 months
Secondary outcomes:
measure: 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
timeFrame: From baseline to 3 months
measure: Number of participants who obtain blood pressure readings for at least 4 timepoints
timeFrame: From baseline to 3 months
measure: Number of participants who obtain electrocardiogram (EKG) readings for at least 4 timepoints
timeFrame: From baseline to 3 months
measure: Rate of cardiovascular therapeutic medication intervention recommendations by the cardio-oncologist
timeFrame: From baseline to 3 months
measure: Rate of compliance with cardiovascular therapeutic medication intervention
timeFrame: From baseline to 3 months
measure: Evaluate participant intervention perspectives at the end of the study.
timeFrame: At 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cancer Clinical Trials Office
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Katelyn Atkins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: