Table 2.
Ongoing prospective trials of RASi to protect against cancer treatment-related side-effects
|
ClinicalTrials.gov identifier (Acronym study) |
Condition, treatment | Design | Intervention | Primary endpoint | Status |
|---|---|---|---|---|---|
|
| |||||
| Cardiotoxicity | |||||
|
| |||||
| NCT03127631 (RADICALPC) | Prostate cancer, androgen deprivation therapy | RCT | SOC | Composite of death, MI, Stroke, HF or Arterial Revascularisation | Recruiting |
| Behavioral interventions (nutrition, exercise, smoking cessation) + ASA + Statin + ACEi | |||||
|
| |||||
| NCT02907021 (SCHOLAR) | HER-2 positive breast cancer (non-metastatic) with moderate LV dysfunction | Single arm, Phase I | ACEi + BB | Development of cardiac dose-limiting toxicity | Not yet recruiting |
|
| |||||
| NCT02236806 (SAFE) | Breast cancer (non-metatstic), anthracyclines ± anti-HER2 | RCT, Phase III | Placebo | LVEF | Unknown |
| Bisoprolol | |||||
| Ramipril | |||||
| Bisoprolol + ramipril | |||||
|
| |||||
| NCT01904903 (SAFE-HEaRT) | HER-2 positive breast cancer with mild LV dysfunction, anti-HER-2 | Single arm, Phase II | ACEi + BB | Completion of therapy without cardiac events or worsening of cardiac function | Recruiting |
|
| |||||
| NCT03265574 (PROACT) | Breast cancer, adjuvant epirubicin | RCT, Phase III | SOC | Cardiac tropinin T relaese, cardiac function | Recruiting |
| Enalapril | |||||
|
| |||||
| NCT01968200 (ICOS-ONE) | Cancer, treatment with anthracyclines | RCT, Phase III | Enalapril (concomitant) | Occurence of cTn elevation | Active, not recruiting |
| Enalapril (after biochemical proven injury) | |||||
|
| |||||
| NCT01009918 | HER-2 positive breast cancer, trastuzumab | RCT, Phase III | Placebo | LVEF | Active, not recruiting |
| Carvedilol (extended release) | |||||
| Lisinopril | |||||
|
| |||||
| Radiotherapy-related toxicities | |||||
|
| |||||
| NCT01805453 (ASTER) | Newly-diagnosed glioblastoma, radiotherapy + temozolomide | RCT, phase II | Placebo | Steroid dose needed to control brain edema after radiotherapy | Active, not recruiting |
| Losartan | |||||
|
| |||||
| NCT01754909 | Lung cancer, radiotherapy | RCT, phase II | Placebo | Radiation pneumonitis | Recruiting |
| Enalapril | |||||
|
| |||||
| NCT01880528 | Lung cancer, radiotherapy | RCT | Placebo | Primary: adverse events of lisinopril -- Secondary: dyspnea, symptoms, QoL | Active, not recruiting |
| Lisinopril | |||||
|
| |||||
| NCT00004230 | Bone marrow or stem cell transplantation, following chemotherapy and radiotherapy | RCT, phase III | SOC | Lung injury | Completed |
| Captopril | |||||
|
| |||||
| Others | |||||
|
| |||||
| NCT02651415 (PARICCA) | Metastatic Colorectal cancer, regorafenib | Single arm, phase II | Perindopril | HFSR, AHT | Active, not recruiting |
Abbreviations: ACEi, angiotensin-converting-enzyme inhibitor; AHT, arterial hypertension; ASA, acetyl salicylic acid; BB, beta blocker; CHOP, cyclophosphamide/doxorubicin/vincristine/prednisolone; cTn, cardiac troponins; HF, heart failure; HFSR, hand-foot skin reaction; LV, left ventricular; LVEF, LV ejection fraction; MI, myocardial infarction; NSCLC, non-small cell lung cancer; QoL, quality of life; RASi, renin-angiotensin system inhibitors; RCT, randomized controlled trial; SOC, standard of care