Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients

Breast cancer is the most common form of cancer in women. Modern breast cancer treatments have led to increased survival, but at the same time, increased risk for cardiotoxicity and development of heart failure. In this study, we want to answer whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. The trial is prospective, randomised, double-blind and placebo-controlled. The primary objective is change in left ventricular ejection fraction (LVEF), determined by cardiac MRI (CMR). Secondary objectives are change in circulating high-sensitivity cardiac troponin I and T, and various measurements of change in left ventricular systolic function determined by CMR and echocardiography. Additional assessments are functional capacity (handgrip strength test, 6-minute walk test), quality of life (EORTC QLQ-C30, EQ-5D-5L and Chalder Fatigue Scale) and circulating creatine kinase and myoglobin.60 patients will be randomised in a 1:1 ratio. The duration of blinded therapy will depend on the duration of anthracycline therapy. All patients will be examined at baseline and 3 months, and if the patient is scheduled for extended anthracycline therapy, an additional examination will be performed at 6 months.

Inclusion Criteria:Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy (weekly doxorubicin, EC-60 etc.)Eastern Cooperative Oncology Group performance status 0-2Exclusion CriteriaAge <18 yearsAcute myocardial infarction within the last three monthsParticipation in another pharmaceutical clinical trial of an investigational medicinal product (IMP) less than 4 weeks prior to inclusion or use of other investigational drugs within 5 half-lives of enrollment, whichever is longerConditions that would affect the participants to comply with the study protocol as psychiatric or mental disorders, alcohol abuse or other substance abuse, suspected poor drug compliance, language barriersLife expectancy < 6 monthsKnown allergy to any of the components in the Niagen® tabletContraindications or inability to undergo CMR examination