Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
Recruiting · NCT05732051 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Akershus
View the official record on ClinicalTrials.gov →Interventions studied
Nicotinamide RibosidePlacebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
- Eastern Cooperative Oncology Group performance status 0-2
Exclusion criteria
- 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
- Life expectancy \< 6 months
- Known allergy to any of the components in the Nicotinamide Riboside (Niagen®) tablet
- Contraindications or inability to undergo CMR examination
Where it is running
1 location listed.
- Akershus University Hospital - Lørenskog, Akershus, Norway