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

University Hospital, Akershus

Status and phase: Enrolling; Phase 2

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

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Nicotinamide Riboside

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05732051

2021/156064(REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Treatment Arm

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nicotinamide Riboside

Placebo Control Arm

Placebo Comparator group

Description:

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:

Dietary Supplement: Placebo