Remote Ischaemic Preconditioning in Childhood Cancer

June 7, 2022 updated by: Professor Yiu-fai Cheung, The University of Hong Kong

Remote Ischaemic Preconditioning in Paediatric Cancer Patients Receiving Anthracycline Therapy

Survival rates of children with cancers have improved significantly in the recent few decades. Nonetheless, the side effect of this class of drugs on heart function remains to be an issue of concern. Exploration of new strategies to protect the heart in the long term is therefore of paramount importance in children undergoing treatment of cancers. Previous cardioprotective interventions hav focused on changing the formulation or rate of administration of anthracyclines but with no observable benefits. While dexrazoxane, an iron chelator, has shown to reduce cardiotoxic outcomes, there remains worries of an association between dexrazoxane use and an increased risk of developing secondary malignancies. Recently, the clinical application of remote ischaemic preconditioning (RIPC) as a non-invasive and an easily applicable non-pharmacological myocardial protective intervention has gained increasing interest. Remote ischaemic preconditioning is the phenomenon in which brief episodes of reversible ischaemia and reperfusion applied to one vascular bed render resistance to ischaemia reperfusion injury of tissues and organs distant away. It can be achieved by repeated 5-minute cycles of inflation and deflation of blood pressure cuff placed over the arm or leg to induce limb ischaemia and reperfusion injury. It is noteworthy that anthracycline cardiotoxicity and myocardial reperfusion injury occur through similar pathways. Hence, the investigators hypothesize that RIPC may reduce myocardial injury in children receiving anthracycline chemotherapy for childhood malignancies. The proposed study aims to conduct a parallel-group blinded randomized controlled trial study to investigate whether RIPC may reduce heart damage in childhood cancer patients undergoing anthracycline-based treatment, and to determine the effect of RIPC on the changes in levels of cardiac troponin T, and on the occurrence of clinical cardiovascular events and echocardiographic indices.

Study Overview

Status

Completed

Conditions

Detailed Description

Remote ischemic preconditioning (RIPC) protocol will be induced at baseline and before each dose of anthracycline cardiac surgery and once before induction of anesthesia by 3 cycles of 5-min upper or lower limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to 15 mmHg above the systolic blood pressure for 5 minutes followed by 5 minutes of cuff deflation to 0 mmHg.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Hong Kong Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients aged 4 to 18 years old
  • newly diagnosed patients with solid tumours or haematological malignancies referred for anthracycline-based chemotherapy
  • no history of being treated with anthracycline-based regimens in the past.

Exclusion Criteria:

  • existence of congenital or acquired heart disease
  • presence of syndromal disorders
  • abnormal baseline echocardiographic assessment
  • peripheral vascular disease that renders RIPC impossible
  • a platelet count <30,000/µL.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention RIPC
The intervention RIPC protocol will be induced by three cycles of inflation of a blood pressure cuff placed over the upper or lower limb, where deemed to cause minimal discomfort to patient, to 15 mmHg above the systolic blood pressure for five minutes followed by five minutes of cuff deflation to 0 mmHg.
The intervention RIPC protocol will be performed each time by three cycles of inflation of a blood pressure cuff placed over the arm or leg of your child, where deemed to cause minimal discomfort, to 15 mmHg above the systolic blood pressure for 5 minutes followed by 5 minutes of cuff deflation to 0 mmHg.
Other Names:
  • Remote Ischemic Conditioning
  • Remote Ischaemic Conditioning
PLACEBO_COMPARATOR: Control
The control protocol involves only placement of blood pressure cuff but without inflation for 30 minutes.
Placement of blood pressure cuff without inflation for 30 minutes.
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High sensitivity cardiac troponin T (hs-cTnT)
Time Frame: hs-cTnT will be measured at baseline, and at 3 months after completion of all anthracycline. The change from baseline hs-cTnT to at 3 months after completion of all anthracycline will be measured.
Biomarker of myocardial injury
hs-cTnT will be measured at baseline, and at 3 months after completion of all anthracycline. The change from baseline hs-cTnT to at 3 months after completion of all anthracycline will be measured.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of clinical cardiovascular events
Time Frame: at baseline, within 1 week and at 3 months after completion of all anthracycline treatment.
Clinical cardiovascular events include development of clinical congestive heart failure, occurrence of cardiac arrhythmias, the need to institute cardiac medications, and cardiac death
at baseline, within 1 week and at 3 months after completion of all anthracycline treatment.
Echocardiographic assessment of left ventricular function
Time Frame: Echocardiographic assessment will be performed at baseline, and within 1 week and at 3 months after completion of all anthracycline treatment.
left ventricular systolic and diastolic function
Echocardiographic assessment will be performed at baseline, and within 1 week and at 3 months after completion of all anthracycline treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yiu-fai Cheung, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ACTUAL)

June 1, 2022

Study Registration Dates

First Submitted

May 16, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (ACTUAL)

May 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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