Completed

NCT Number: NCT04805346

Remote Ischemic Conditioning in Oncology

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.

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Key information

Conditions

Participants Undergoing Anthracycline Chemotherapy

Age range

11 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

autoRIC®

Device

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

Primary outcomes

Adverse Effects

Time frame: 18-24 months from start of enrollment

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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Acronym: RICO

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Mar 18, 2021
Registry last updated: Sep 26, 2024

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.