RecruitingRecruiting
Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
NCT05732051 · University Hospital, Akershus
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines
About this study
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 (hs-TnI and hs-TnT), Creatine Kinase (CK) and myoglobin, and various measurements of change in left ventricular systolic function determined by CMR and echocardiography. Additional assessments are evaluation of the patient's functional capacity and the patients will be asked to fill out questionnaires to assess quality of life.
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.
Eligibility criteria
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
Study design
Enrollment target: 60 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2023-03-16
Estimated completion: 2035-09-30
Last updated: 2023-03-17
Interventions
Dietary Supplement: Nicotinamide RibosideDietary Supplement: Placebo
Primary outcomes
- • 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)
Sponsor
University Hospital, Akershus · other
With: ChromaDex, Inc., Norwegian Cancer Society, Norwegian Breast Cancer Association, Helse Sor-Ost
Contacts & investigators
ContactTorbjørn Omland, MD, PhD · contact · torbjorn.omland@medisin.uio.no · +47 40107050
ContactVictoria Vinje, MD · contact · victoria.vinje@ahus.no · +47 92033665
InvestigatorTorbjørn Omland, MD, PhD · principal_investigator, University Hospital, Akershus
All locations (1)
Akershus University HospitalRecruiting
Lørenskog, Akershus, Norway