Breast CancerMetastatic Breast CancerCancer Therapy-Related Cardiac DysfunctionCardiotoxicityHeart Failure
Investigational drug(s) / intervention(s)
Nicotinamide RibosidePlacebo
Nicotinamide Riboside: Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
Placebo: Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Study summary
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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Whether the administration of nicotinamide riboside can prevent the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR), compared to placebo. — Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy.
Trial sites (1)
Facility
City
Region
Status
Akershus University Hospital
Lørenskog
Akershus
Recruiting
More University Hospital, Akershus trials in Norway
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
