Using Nicotinamide Riboside to Prevent Heart Problems in Breast Cancer Patients
Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines
PHASE2 · University Hospital, Akershus · NCT05732051
This study is trying to see if a supplement called nicotinamide riboside can help prevent heart problems in women with metastatic breast cancer who are receiving certain chemotherapy treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Akershus (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lørenskog, Akershus) |
| Trial ID | NCT05732051 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of nicotinamide riboside in preventing cardiac dysfunction in women with metastatic breast cancer who are undergoing anthracycline chemotherapy. It is a prospective, randomized, double-blind, and placebo-controlled study involving 60 participants. The primary outcome will be measured by changes in left ventricular ejection fraction using cardiac MRI, while secondary outcomes will include various cardiac biomarkers and assessments of functional capacity and quality of life. Participants will be monitored at baseline, 3 months, and potentially 6 months, depending on their treatment duration.
Who should consider this trial
Good fit: Ideal candidates are women with stage IV metastatic breast cancer scheduled for anthracycline-containing chemotherapy.
Not a fit: Patients under 18 years old or those with recent heart issues or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart-related complications in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While there is ongoing research into cardioprotective agents in cancer therapy, the specific use of nicotinamide riboside in this context is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Lørenskog, Akershus
- Akershus University Hospital — Lørenskog, Akershus, Norway (RECRUITING)
Study contacts
- Principal investigator: Torbjørn Omland, MD, PhD — University Hospital, Akershus
- Study coordinator: Torbjørn Omland, MD, PhD
- Email: torbjorn.omland@medisin.uio.no
- Phone: +47 40107050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer, Metastatic Breast Cancer, Cancer Therapy-Related Cardiac Dysfunction, Cardiotoxicity, Heart Failure, Anthracyclines, Niagen, Nicotinamide riboside