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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
60
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Akershus University Hospital
Lørenskog, Akershus, Norway
RECRUITINGWhether 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.
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
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
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
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
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
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
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
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
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin T (hs-cTnT)
From randomization to the end of blinded therapy: Change in circulating hs-cTnT
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin I (hs-cTnI)
From randomization to the end of blinded therapy: Change in circulating hs-cTnI
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity
From randomization to the end of blinded therapy: Change in distance in meters during 6-minute walk test
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity
From randomization to the end of blinded therapy: Change in force generated by handgrip strength test
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
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