Remote Ischaemic Preconditioning in Childhood Cancer
Condition: Cardiotoxicity
MeSH terms: Cardiotoxicity
Study type: Interventional

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.
    

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.
    

Intervention name(s): Remote Ischaemic Preconditioning; Control
Intervention type(s): Procedure; Other
Intervention description(s): 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.; Placement of blood pressure cuff without inflation for 30 minutes.
Other intervention name(s): Remote Ischemic Conditioning; Remote Ischaemic Conditioning; Sham
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remote ischaemic preconditioning; childhood cancer; cardio-oncology; anthracycline; myocardial reperfusion injury