A Phase 2 interventional study of Nicotinamide Riboside and Placebo in Breast Cancer, Metastatic Breast Cancer and Cancer Therapy-Related Cardiac Dysfunction, sponsored by University Hospital, Akershus. Recruiting at 1 site in Norway. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-17.
Sponsored by University Hospital, Akershus · Phase 2, Interventional, and Prevention
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria
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.
Dietary Supplement: Nicotinamide Riboside
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.
Dietary Supplement: Placebo
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
Also known as: Niagen (serial number 85932490, registration number 4606519)
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Whether 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
Pharmacological endpoint: Change in circulating Nicotinamide adenine dinucleotide (NAD+) concentration from baseline to end of blinded therapy.
Changes in the amount of circulating NAD+ will be measured using commercial kits and Liquid chromatography-mass spectrometry analyses (LC-MS analyses)
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less myocardial injury expressed as oedema or fibrosis by CMR
Change in transverse relaxation time (T2) 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
Tertiary objective: Less myocardial injury expressed as oedema or fibrosis by CMR
Change in longitudinal relaxation time (T1) 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
Tertiary objective: Less myocardial injury expressed as oedema or fibrosis by CMR
Change in T1 rho 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
Tertiary objective: Less reduction in left ventricular diastolic function measured by echocardiography
Change in left ventricular diastolic function as measured by echocardiography
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less aortic stiffness measured by CMR
Change in the aortic pulse wave velocity 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
Tertiary objective: Less myocardial injury and dysfunction measured by cardiac biomarkers other than troponin
Chance in circulating N-terminal pro b-type natriuretic peptide (NT-proBNP)
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less myocardial injury and dysfunction measured by cardiac biomarkers other than troponin
Chance in circulating cardiac myosin binding protein C (cMyC)
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less skeletal muscle injury
Change in circulating creatine kinase (CK)
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less skeletal muscle injury
Change in circulating myoglobin
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less worsening in health-related quality of life
Quality of life measured by Chalder Fatigue Scale. Items are rated on a 4-point Likert scale (0 = better than usual, 1 = no more than usual, 2 = worse than usual, 3 = much worse than usual), with higher scores indicating greater fatigue.
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less worsening in health-related quality of life
Quality of life measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / Quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Tertiary objective: Less worsening in health-related quality of life
Quality of life measured by European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L). Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Plan to share: No
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University Hospital, Akershus