drugset / Trial / NCT03265574
PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?
Phase 3
Completed
111 enrolled
South Tees Hospitals NHS Foundation Trust
Newcastle University · collabNewcastle-upon-Tyne Hospitals NHS Trust · collabUniversity of Durham · collab
RandomizedParallel-groupSingle-blindPrevention
Summary
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.
Timeline
- Start
- 2017-10-04
- Primary completion
- 2023-08-04
- Completion
- 2023-08-04
Outcome
Missed primary endpoint
paper Adding enalapril to standard care during chemotherapy did not prevent cardiotoxicity in patients receiving high-dose anthracycline-based chemotherapy. PMID 39479329 ↗
Publications
- Austin D, Maier RH, Akhter N, Sayari M, Ogundimu E, Maddox JM, Vahabi S, Humphreys AC, Graham J, Oxenham H, Haney S, Cresti N, Verrill M, Osborne W, Wright KL, Goranova R, Bailey JR, Kalakonda N, Macheta M, Kilner MF, Young ME, Morley NJ, Neelakantan P, Gilbert G, Thomas BK, Graham RJ, Fujisawa T, Mills NL, Hildreth V, Prichard J, Kasim AS, Hancock HC, Plummer C. Preventing Cardiac Damage in Patients Treated for Breast Cancer and Lymphoma: The PROACT Clinical Trial. JACC CardioOncol. 2024 Aug 27;6(5):684-696. doi: 10.1016/j.jaccao.2024.07.010. eCollection 2024 Oct.
- Maier RH, Plummer C, Kasim AS, Akhter N, Ogundimu E, Maddox J, Graham J, Stewart M, Wardley A, Haney S, Vahabi S, Oxenham H, Humphreys A, Cresti N, Verrill M, Graham R, Chang L, Hancock HC, Austin D. Preventing cardiotoxicity in patients with breast cancer and lymphoma: protocol for a multicentre randomised controlled trial (PROACT). BMJ Open. 2022 Dec 30;12(12):e066252. doi: 10.1136/bmjopen-2022-066252.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enalapril | Other / unclassified | 20 mg | — |