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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 27, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07897409). This is a study registration, not published results. Lead sponsor: Universiti Sains Malaysia. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 146 participants (ESTIMATED). Conditions: Doxorubicin Induced Cardiotoxicity, Doxorubicin Induced Cardiomyopathy, Doxorubicin, Doxorubicin Adverse Reaction. Interventions: DRUG: Nicorandil Oral Tablet; DRUG: Adriamycin (Doxorubicin). Primary outcome measures: To evaluate the effect of nicorandil on left ventricular ejection fraction in breast cancer patients receiving doxorubicin. , before the treatment initiation, at the 3rd and the 6th months of the treatment initiation; To evaluate the safety of nicorandil , before the treatment initiation, at the 3rd and the 6th months of the treatment initiation. Brief summary: Breast cancer is one of the world's most common cancers in females. Most of the chemotherapy protocols used to treat breast cancer involve doxorubicin. Doxorubicin has a very significant antitumor effect on breast tumors. One of the obstacles that hinders the use of doxorubicin is cardiotoxicity. Although many agents are used to address this issue, only dexrazoxane is FDA-approved. One suggested pathway for doxorubicin-induced cardiotoxicity is due to calcium imbalance. Calcium ions are very important in controlling the heart's function. Nicorandil is an anti-anginal agent that shows cardioprotective effects against doxorubicin-induced cardiotoxicity in preclinical trials. Not only that, but preclinical studies on rats and mice have also shown that it has antitumor and augmenting effects on doxorubicin's anticancer properties. Here in our trial, the impact of the nicorandil will be assessed on breast cancer patients. The chosen method will be a parallel, open-label, randomized clinical trial. The selected sampling method will be stratified blocks based on radiotherapy and HFA-ICOS baseline scores. The sample size will be 146 patients, who will be randomized using a premuted block. The primary parameter will be the ejection fraction. The secondary parameters will include cardiac troponins, creatine kinase myocardial band, safety assessment of nicorandil use on the gastrointestinal and cardiovascular systems, quality of life after nicorandil use, cost-effectiveness and cost-utility of nicorandil, and the quality of life and baseline cardiac scoring system.