Remote Ischemic Conditioning in Oncology (RICO)

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Participants Undergoing Anthracycline Chemotherapy

Treatments: Device: autoRIC®

Study type: Interventional

Funder types: Other

Identifiers

NCT04805346

2020-0708 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 11+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pediatric, adolescent, or young adult patients, 11 years of age or above.
2. Able to tolerate upper arm blood pressure inflation.

Exclusion criteria

1. Previous diagnosis of cardiomyopathy (dilated, hypertrophic, restrictive, myocarditis) or congenital heart disease other than bicuspid aortic valve.
2. Chronic kidney disease as defined as a pre-transplant GFR <80
3. Central line in both upper extremities.
4. Known peripheral vascular disease or vasculitis.
5. Platelet count less than 30,000.
6. Known clotting disorder or hypercoagulability
7. Non-English-speaking patients.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

Therapeutic Group

Experimental group

Description:

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).

Treatment:

Device: autoRIC®

Control Group

No Intervention group

Description:

A control group will undergo a similar procedure, but the cuff will not be inflated.