Remote Ischemic Conditioning in Oncology

Participants Undergoing Anthracycline Chemotherapy Clinical Trial

— RICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805346
• Other study ID #: 2020-0708
• Status: Completed
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: May 3, 2024

Study information

• Verified date: June 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: May 3, 2024
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Participants Undergoing Anthracycline Chemotherapy

Intervention

Device:
• autoRIC®
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

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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