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, the investigators want to evaluate whether nicotinamide riboside can prevent cancer-related cardiac dysfunction in metastatic breast cancer patients scheduled for anthracycline therapy. Further, the investigators will evaluate change in signs of skeletal muscle injury and functional capacity.
Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
Eastern Cooperative Oncology Group performance status 0-2
Age <18 years
Acute myocardial infarction within the last three months
Participation 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 longer
Conditions 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 barriers
Parallel
Nicotinamide Riboside
Dietary supplementNicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
Placebo
Dietary supplementMatching placebo b.i.d as long as the patient is receiving anthracycline therapy
Whether the administration of nicotinamide riboside can prevent the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR), compared to placebo.
Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy.
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography
From randomization to the end of blinded therapy: Change in LVEF, as determined by echocardiography
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography
From randomization to the end of blinded therapy: Change in left ventricular global longitudinal strain (GLS), as determined by echocardiography
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR
From randomization to the end of blinded therapy: Change in left ventricular global circumferential strain (GCS) and GLS, as determined by CMR
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR
From randomization to the end of blinded therapy: Change in left ventricular end-systolic volume measured by CMR
Pharmacological endpoint: Change in circulating Nicotinamide adenine dinucleotide (NAD+) concentration from baseline to end of blinded therapy.
Changes in the amount of circulating NAD+ will be measured using commercial kits and Liquid chromatography-mass spectrometry analyses (LC-MS analyses)
Tertiary objective: Less myocardial injury expressed as oedema or fibrosis by CMR
Change in transverse relaxation time (T2) measured by CMR
Tertiary objective: Less myocardial injury expressed as oedema or fibrosis by CMR
Change in longitudinal relaxation time (T1) measured by CMR
Tertiary objective: Less myocardial injury expressed as oedema or fibrosis by CMR
Change in T1 rho measured by CMR
Map coordinates are unavailable for these locations. Locations are shown below instead.
NorwayClick on the lead sponsor to view all of their trials.
University Hospital, Akershus
Lead sponsor
ChromaDex, Inc.
Collaborator
Norwegian Cancer Society
Collaborator
Norwegian Breast Cancer Association
Collaborator
Helse Sor-Ost
Collaborator
