PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymph… (NCT03265574) | Clinical Trial Compass
CompletedPhase 3
PROACT: Can we Prevent Chemotherapy-related Heart Damage in Patients With Breast Cancer and Lymphoma?
United Kingdom111 participantsStarted 2017-10-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent.
* Adult patients with histopathologically\* confirmed breast carcinoma who have received surgery for their breast cancer; planned to receive 6 cycles of EC 90 (total planned dose 540mg/m2 epirubicin) or FEC 75 (total planned dose 450mg/m2 epirubicin) adjuvant chemotherapy regimen. Patients with HER2+ breast cancer are eligible for inclusion.
OR
* Adult patients with histopathologically confirmed non-Hodgkin lymphoma (NHL), planned to receive 6 cycles of R-CHOP or CHOP (total planned dose 300mg/m2 doxorubicin) chemotherapy\*\*
* Patients with HER2+ breast cancer are eligible for inclusion. \*\* Patients who will receive an alternative anti-CD20 monoclonal antibody are eligible (for example O-CHOP), as long as the total planned doxorubicin dose is ≥300mg/m2 over 6 cycles
Exclusion Criteria:
* Positive baseline cardiac troponin T (≥14ng/L);
* known contraindication to ACE inhibitor e.g. renal artery stenosis, severe aortic stenosis;
* are taking, or have a previous intolerance to ACEI (e.g. angioedema);
* patient already taking other agents acting on the renin-angiotensin-aldosterone system e.g. Aliskiren, angiotensin receptor blockers (ARBs), Entresto (sacubitril/valsartan), spironolactone, eplerenone;
* LVEF \<50%\*;
* estimated GFR \< 30 mL/min/1.73m2 at baseline;
* hyperkalaemia defined as serum potassium ≥5.5mmol/L;
* symptomatic hypotension, or Systolic Blood Pressure \<100mmHg;
* poorly-controlled hypertension (Blood…
What they're measuring
1
Cardiac troponin T release
Timeframe: One month after last dose of anthracycline