NCT05732051 Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
| NCT ID | NCT05732051 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Akershus |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-03-16 |
| Primary Completion | 2025-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-03-16 with a primary completion date of 2025-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Torbjørn Omland, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Akershus
Frequently Asked Questions
Who can join the NCT05732051 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05732051 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05732051 currently recruiting?
Yes, NCT05732051 is actively recruiting participants. Contact the research team at torbjorn.omland@medisin.uio.no for enrollment information.
Where is the NCT05732051 trial being conducted?
This trial is being conducted at Lørenskog, Norway.
Who is sponsoring the NCT05732051 clinical trial?
NCT05732051 is sponsored by University Hospital, Akershus. The principal investigator is Torbjørn Omland, MD, PhD at University Hospital, Akershus. The trial plans to enroll 60 participants.
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