Remote Ischaemic Preconditioning in Childhood Cancer

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT03166813
Collaborator
(none)
68
1
2
59
1.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Remote Ischaemic Preconditioning
  • Other: Control
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Remote Ischaemic Preconditioning in Paediatric Cancer Patients Receiving Anthracycline Therapy
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Arms and Interventions

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.

Procedure: Remote Ischaemic Preconditioning
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.

    Other: Control
    Placement of blood pressure cuff without inflation for 30 minutes.
    Other Names:
  • Sham
  • Outcome Measures

    Primary Outcome Measures

    1. High sensitivity cardiac troponin T (hs-cTnT) [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

    Secondary Outcome Measures

    1. Occurrence of clinical cardiovascular events [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

    2. Echocardiographic assessment of left ventricular function [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hong Kong Children's Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Professor Yiu-fai Cheung, Clinical Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT03166813
    Other Study ID Numbers:
    • UW17-143
    First Posted:
    May 25, 2017
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Professor Yiu-fai Cheung, Clinical Professor, The University of Hong Kong
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 8, 2022