PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI) enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and non-Hodgkin lymphoma undergoing adjuvant epirubicin-based chemotherapy.
PROACT is a phase 3 randomised, open label, blinded endpoint, superiority trial of enalapril to prevent anthracycline-induced in patients treated for breast cancer and lymphoma. Anthracyclines used in the treatment of breast cancer cause damage to heart muscle cells; this results in cell death (cardiotoxicity). In UK contemporary practice, epirubicin is the most frequently used anthracycline. Patients due to receive adjuvant anthracycline chemotherapy (planned epirubicin dose \>300mg/m2) for breast cancer at four specialist centres in the North of England will be invited to participate. 170 eligible patients will be randomised in a 1:1 ratio, to either enalapril plus usual care or to usual care. Enalapril will be commenced prior to the first anthracycline dose, titrated to a maximum tolerated dose, and continued during chemotherapy. Chemotherapy will continue per usual care; typically six treatment cycles. Patients will have a blood test performed at the end of each chemotherapy cycle to measure cardiac troponin, and at one month following the last epirubicin dose. Investigators and patients will be blinded to the troponin results. Patients will have an echocardiogram at baseline and following their chemotherapy; they will be assessed in a blinded manner by a central Core Laboratory.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
111
Enalapril is an Angiotensin Converting Enzyme (ACE) inhibitor which supresses the reninangiotensin-aldosterone system resulting in increased plasma renin activity and decreased aldosterone secretion
South Tees Hospitals NHS FT
Middlesbrough, Teesside, United Kingdom
Cardiac troponin T release
Cardiac troponin T release during anthracycline treatment
Time frame: One month after last dose of anthracycline
Cardiac function
Cardiac function assessed by echocardiogram
Time frame: One month after last dose of anthracycline
Adherence to enalapril
Ability of participant to adhere to enalapril
Time frame: One month after last dose of anthracycline
Adverse Events / Reactions
Number and severity of Adverse Events and Reactions
Time frame: One month after last dose of anthracycline
Anxiety or distress related to trial participation
Anxiety or distress related to trial participation
Time frame: One month after last dose of anthracycline
Cancer and chemotherapy outcomes
Cancer and chemotherapy outcomes in the population under study
Time frame: One month after last dose of anthracycline
Cardiac troponin I release
cardiac troponin I release during anthracyline treatment
Time frame: One month after last dose of anthracycline
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