Deakin University
Browse

File(s) under embargo

Preventing cardiotoxicity in patients with breast cancer and lymphoma: protocol for a multicentre randomised controlled trial (PROACT)

journal contribution
posted on 2023-10-10, 05:35 authored by Rebecca H Maier, Chris Plummer, Adetayo S Kasim, Nasima Akhter, Emmanuel Ogundimu, Jamie Maddox, Janine Graham, Michael Stewart, Andrew Wardley, Sophie Haney, Sharareh Vahabi, Helen Oxenham, Alison Humphreys, Nicola Cresti, Mark Verrill, Richard Graham, Lisa Chang, Helen C Hancock, David AustinDavid Austin
IntroductionAnthracyclines are included in chemotherapy regimens to treat several different types of cancer and are extremely effective. However, it is recognised that a significant side effect is cardiotoxicity; anthracyclines can cause irreversible damage to cardiac cells and ultimately impaired cardiac function and heart failure, which may only be evident years after exposure. The PROACT trial will establish the effectiveness of the ACE inhibitor enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and non-Hodgkin’s lymphoma (NHL) receiving anthracycline-based chemotherapy.Methods and analysisPROACT is a prospective, randomised, open-label, blinded end-point, superiority trial which will recruit adult patients being treated for breast cancer and NHL at NHS hospitals throughout England. The trial aims to recruit 106 participants, who will be randomised to standard care (high-dose anthracycline-based chemotherapy) plus enalapril (intervention) or standard care alone (control). Patients randomised to the intervention arm will receive enalapril (starting at 2.5 mg two times per day and titrating up to a maximum dose of 10 mg two times per day), commencing treatment at least 2 days prior to starting chemotherapy and finishing 3 weeks after their last anthracycline dose. The primary outcome is the presence or absence of cardiac troponin T release at any time during anthracycline treatment, and 1 month after the last dose of anthracycline. Secondary outcomes will focus on cardiac function measured using echocardiogram assessment, adherence to enalapril and side effects.Ethics and disseminationA favourable opinion was given following research ethics committee review by West Midlands—Edgbaston REC, Ref: 17/WM/0248. Trial findings will be disseminated through engagement with patients, the oncology and cardiology communities, NHS management and commissioning groups and through peer-reviewed publication.Trial registration numberNCT03265574.

History

Journal

BMJ OPEN

Volume

12

Article number

ARTN e066252

Location

England

ISSN

2044-6055

eISSN

2044-6055

Language

English

Issue

12

Publisher

BMJ PUBLISHING GROUP