Effect of Remote Ischaemic Conditioning in Oncology Patients (ERICONC)
Research type
Research Study
Full title
A single centre double-blinded randomized placebo controlled pilot study investigating the Effect of Remote Ischaemic preConditioning in ONCology patients undergoing chemotherapy (ERICONC)
IRAS ID
178001
Contact name
Derek Yellon
Contact email
Sponsor organisation
UCL
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
R&D reference, 15/0276
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
Cancer survival has improved steadily due to earlier detection and treatment. Despite the established efficacy of anthracycline chemotherapy, its damaging effects on the heart (cardiotoxicity) limits treatment and confers acute and long term adverse cardiovascular consequences. Protective strategies for the heart (cardioprotection) with iron binders (chelation), heart rate (beta blockade) and blood pressure (renin angiotensin inhibition) medications have demonstrated promise in adult cancer patients, but these treatments are typically prescribed only after significant changes in heart chamber size and pumping ability are detected by imaging investigations ( myocardial dysfunction). Furthermore, these conventional therapies are constrained by important side effects that affect bone marrow, blood pressure, and the kidneys.
Remote ischaemic conditioning (RIC) protects the heart by activating cell survival pathways through brief repeated inflations and deflations of a blood pressure cuff to limit blood flow temporarily (non-injurious ischaemia). These innate survival mechanisms prevent part of the cellular injury that occurs during the ischaemia- reperfusion cascade during a heart attack (myocardial infarction). Ischaemia-reperfusion injury also shares common biochemical pathways with anthracycline cardiotoxicity, and thus RIC may be a novel form of non-pharmacological cardioprotection that can be applied when undergoing anthracycline chemotherapy.
We propose a pilot single centre randomised-controlled trial to investigate the effect of RIC on reducing heart muscle damage (myocardial injury) in anthracycline-treated cancer patients. We will assess sub-clinical myocardial injury using high-sensitivity blood tests (troponin T levels) and advanced imaging techniques, monitor heart rhythm disturbances (cardiac arrhythmia) and analyse metabolic changes in urine and blood during chemotherapy.
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1116
Date of REC Opinion
28 Jul 2015
REC opinion
Further Information Favourable Opinion