Abstract
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.
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.
| Original language | English |
|---|---|
| Article number | e066252 |
| Journal | BMJ Open |
| Volume | 12 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 30 Dec 2022 |
| Externally published | Yes |