Remote Ischemic Conditioning in Oncology

Study Overview
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Brief Summary
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This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients undergoing anthracycline chemotherapy for Hodgkin disease and soft-tissue and bone sarcoma who meet eligibility requirements will be approached to participate in the study. The purpose of the study is to determine if performing remote ischemic conditioning (RIC) is feasible in children and young adults receiving anthracycline chemotherapy. The secondary purpose is to describe differences in markers of myocardial injury and stress in children and young adults that receive RIC prior to anthracycline chemotherapy compared to control subjects that receive sham therapy prior to chemotherapy.

Official Title
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Remote Ischemic Conditioning for Protection From Treatment-related Cardiotoxicity in Pediatric, Adolescent, and Young Adult Patients Undergoing Anthracycline Chemotherapy

Conditions
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Participants Undergoing Anthracycline Chemotherapy

Intervention / Treatment
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* Device: autoRIC®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric, adolescent, or young adult patients, 11 years of age or above. Able to tolerate upper arm blood pressure inflation. Exclusion Criteria: Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve. Chronic kidney disease as defined as a pre-transplant GFR <80 Central line in both upper extremities. Known peripheral vascular disease or vasculitis. Platelet count less than 30,000. Known clotting disorder or hypercoagulability Non-English-speaking patients.

Ages Eligible for Study
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Minimum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Group<br>With the patient sitting upright in bed or a chair, the remote ischemic conditioning intervention will consist of 4 automatic cycles of upper arm blood pressure cuff inflation to 200 mm Hg for 5 minutes to induce transient, noninjurious, limb ischemia, followed by cuff deflation for 5 minutes, for a total of 35 minutes (autoRIC®, Cellaegis Devices, Mississauga, ON, Canada). The remote ischemic preconditioning cycles will be performed by trained research personnel prior to each cycle of chemotherapy (total treatments variable based on chemotherapy protocol). | Device: autoRIC®<br>* With the patient sitting upright in bed or a chair, the remote ischemic conditioning intervention will consist of 4 automatic cycles of upper arm blood pressure cuff inflation to 200 mm Hg for 5 minutes to induce transient, noninjurious, limb ischemia, followed by cuff deflation for 5 minutes, for a total of 35 minutes (autoRIC®, Cellaegis Devices, Mississauga, ON, Canada).17 The remote ischemic preconditioning cycles will be performed by trained research personnel prior to each cycle of chemotherapy (total treatments variable based on chemotherapy protocol<br>|
| No Intervention: Control Group<br>A control group will undergo a similar procedure, but the cuff will not be inflated. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Effects | Patients with intra-thoracic disease may also receive consolidative radiation that includes portions of the myocardium within the radiation field and thus further increase their risk of developing therapy-related cardiomyopathy. Thus, the development of cardioprotective strategies during therapy for these malignancies is of primary interest to minimize the potential late adverse effects of anthracyclines among the long term survivors of these conditions. | 18-24 months from start of enrollment |