Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients

Phase 2

Recruiting

• Conditions: Cancer Therapy-Related Cardiac Dysfunction; Cardiotoxicity; Heart Failure; Breast Cancer; Metastatic Breast Cancer

• 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.

Study Timeline

• Study First Submitted: 2023-01-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-16
• Study Start: 2023-03-16
• Last Update Submitted: 2023-03-16
• Last Update Posted: 2023-03-17
• Primary Completion: 2025-08-01
• Study Completion: 2035-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 echocardiography
To 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-cTnT
Assess 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 CMR
To 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-cTnI
To 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