Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
- Conditions
- Cancer Therapy-Related Cardiac DysfunctionCardiotoxicityHeart FailureBreast CancerMetastatic Breast Cancer
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Nicotinamide Riboside
- Registration Number
- NCT05732051
- Lead Sponsor
- University Hospital, Akershus
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Control Arm Placebo The patients randomised into this arm of the trial will receive a matching placebo b.i.d. The duration of treatment is equivalent to the description in the treatment arm. Treatment Arm Nicotinamide Riboside The patients randomised into this arm of the trial will receive 500 mg Nicotinamide Riboside b.i.d. The duration of blinded therapy will depend on the duration of anthracycline therapy, and will for some patients last for 3 months, others for 6 months.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy From randomization to the end of blinded therapy:
Change in left ventricular global longitudinal strain (GLS), as determined by echocardiographyTo assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin T (hs-cTnT) Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy From randomization to the end of blinded therapy:
Change in circulating hs-cTnTAssess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy From randomization to the end of blinded therapy:
Change in left ventricular end-systolic volume measured by CMRTo assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin I (hs-cTnI) Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy From randomization to the end of blinded therapy:
Change in circulating hs-cTnITo assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy From randomization to the end of blinded therapy:
Change in force generated by handgrip strength test
Trial Locations
- Locations (1)
Akershus University Hospital
🇳🇴Lørenskog, Akershus, Norway