NCT05732051

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

Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University Hospital, Akershus · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Nicotinamide Riboside	Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
DIETARY_SUPPLEMENT	Placebo	Matching placebo b.i.d as long as the patient is receiving anthracycline therapy

Timeline

• Start date: 2023-03-16
• Primary completion: 2025-08-01
• Completion: 2035-09-30
• First posted: 2023-02-16
• Last updated: 2023-03-17

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated drug study