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autoRIC® for Chemotherapy Patients (RICO Trial)

Q: What is the scope of involvement in this trial?

<p>Affirmative, according to information on clinicaltrials.gov this investigation is actively looking for volunteers. The first posting was made on April 30th 2021 and the latest update occurred June 24th 2022. This trial requires 30 participants drawn from a single medical site.</p>

Q: Has the enrollment for this trial ceased or is it still accepting participants?

<p>Indeed, the clinical trial is actively enrolling participants. Per data on clinicaltrials.gov, it was initially posted in April 2021 and most recently updated in June 2022. The endeavour requires 30 patients from one medical site to participate.</p>

N/A

Waitlist Available

Led By Thomas C Ryan

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pediatric, adolescent, or young adult patients, 11 years of age or above.

Able to tolerate upper arm blood pressure inflation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18-24 months from start of enrollment

Awards & highlights

RICO Trial Summary

This trial is testing whether a cardiac stress-reducing technique is feasible in children and young adults receiving cancer chemotherapy, and if it impacts markers of myocardial injury.

Who is the study for?

This trial is for children and young adults aged 11 or older who are undergoing chemotherapy for Hodgkin disease, soft-tissue, or bone sarcoma. They must be able to handle blood pressure cuff inflation on their arm. It's not suitable for those with central lines in both arms, low platelet counts, clotting disorders, non-English speakers, chronic kidney disease (GFR <80), vascular diseases, or a history of cardiomyopathy or congenital heart disease.Check my eligibility

What is being tested?

The study tests the feasibility of remote ischemic conditioning (RIC) using autoRIC® in patients receiving anthracycline chemotherapy. RIC involves briefly cutting off blood flow to a limb and then restoring it. The goal is to see if this can reduce heart damage from chemo compared to sham therapy—a fake treatment used as a control.See study design

What are the potential side effects?

While the side effects specific to RIC aren't detailed here, typical risks may include discomfort from the blood pressure cuff during RIC procedure and potential bruising where the cuff is applied.

RICO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 11 years old or older.

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I can have my blood pressure taken on my upper arm.

RICO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18-24 months from start of enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18-24 months from start of enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18-24 months from start of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Effects

RICO Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic GroupExperimental Treatment1 Intervention

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).

Group II: Control GroupActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,566 Total Patients Enrolled

Thomas C RyanPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

1 Previous Clinical Trials

16 Total Patients Enrolled

Media Library

autoRIC® Clinical Trial Eligibility Overview. Trial Name: NCT04805346 — N/A

Participants Undergoing Chemotherapy Research Study Groups: Therapeutic Group, Control Group

Participants Undergoing Chemotherapy Clinical Trial 2023: autoRIC® Highlights & Side Effects. Trial Name: NCT04805346 — N/A

autoRIC® 2023 Treatment Timeline for Medical Study. Trial Name: NCT04805346 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of involvement in this trial?

"Affirmative, according to information on clinicaltrials.gov this investigation is actively looking for volunteers. The first posting was made on April 30th 2021 and the latest update occurred June 24th 2022. This trial requires 30 participants drawn from a single medical site."

Answered by AI

Has the enrollment for this trial ceased or is it still accepting participants?

"Indeed, the clinical trial is actively enrolling participants. Per data on clinicaltrials.gov, it was initially posted in April 2021 and most recently updated in June 2022. The endeavour requires 30 patients from one medical site to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Remote Ischemic Conditioning in Oncology

2021. "Remote Ischemic Conditioning in Oncology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04805346.

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