The PROACT trial is a protocol designed to evaluate whether enalapril prevents cardiotoxicity in 106 patients receiving anthracycline-based chemotherapy for breast cancer and lymphoma.
RCT (n=106)
open-label, blinded end-point
randomised
Yes
Does enalapril prevent cardiac troponin T release in adult patients receiving high-dose anthracycline-based chemotherapy for breast cancer and NHL?
The PROACT trial will evaluate whether prophylactic enalapril prevents anthracycline-induced cardiotoxicity (measured by troponin T release) in patients with breast cancer and non-Hodgkin's lymphoma.
INTRODUCTION: Anthracyclines 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 ANALYSIS: PROACT 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 DISSEMINATION: A 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 NUMBER: NCT03265574.
Maier et al. (Thu,) conducted a rct in Breast cancer and non-Hodgkin's lymphoma (n=106). Enalapril vs. Standard care alone was evaluated on Presence or absence of cardiac troponin T release at any time during anthracycline treatment, and 1 month after the last dose of anthracycline. The PROACT trial is a protocol designed to evaluate whether enalapril prevents cardiotoxicity in 106 patients receiving anthracycline-based chemotherapy for breast cancer and lymphoma.