RecruitingPhase 2NCT05732051

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


Sponsor

University Hospital, Akershus

Enrollment

60 participants

Start Date

Mar 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

  • Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
  • Eastern Cooperative Oncology Group performance status 0-2

Exclusion Criteria7

  • 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

Interventions

DIETARY_SUPPLEMENTNicotinamide Riboside

Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy

DIETARY_SUPPLEMENTPlacebo

Matching placebo b.i.d as long as the patient is receiving anthracycline therapy


Locations(1)

Akershus University Hospital

Lørenskog, Akershus, Norway

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NCT05732051


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