Participants Undergoing Anthracycline ChemotherapyRICONCT04805346
Remote Ischemic Conditioning in Oncology
A study testing autoRIC® in people with Participants Undergoing Anthracycline Chemotherapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Participants Undergoing Anthracycline Chemotherapy
- What is being tested?
- autoRIC®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2021to 3 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pediatric, adolescent, or young adult patients, 11 years of age or above.
- Able to tolerate upper arm blood pressure inflation.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
About this study
Official title: Remote Ischemic Conditioning for Protection from Treatment-related Cardiotoxicity in Pediatric, Adolescent, and Young Adult Patients Undergoing Anthracycline Chemotherapy
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.
- Being tested
- autoRIC®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Group | Experimental | 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). Receives: Device: autoRIC® |
| Control Group | No intervention | A control group will undergo a similar procedure, but the cuff will not be inflated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18-24 months from start of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start30 Apr 2021
- Primary completion1 Jul 2023
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Participants Undergoing Anthracycline ChemotherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas C Ryan, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805346
- Sponsor's protocol ID
- 2020-0708
- Acronym
- RICO
- Status last verified
- Sep 2024
- First submitted
- 17 Mar 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning for Protection from Treatment-related Cardiotoxicity in Pediatric, Adolescent, and Young Adult Patients Undergoing Anthracycline Chemotherapy
- ClinicalTrials.gov ID
- NCT04805346
- Acronym / sponsor ID
- RICO / 2020-0708
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Group | Experimental | 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). 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). |
| Control Group | No intervention | –A control group will undergo a similar procedure, but the cuff will not be inflated. |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pediatric, adolescent, or young adult patients, 11 years of age or above.
- Able to tolerate upper arm blood pressure inflation.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Therapeutic Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C Ryan principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoRIC® in people with Participants Undergoing Anthracycline Chemotherapy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Effects (time frame: 18-24 months from start of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.