NCT05732051RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Jan 2023
- Start date
- 16 Mar 2023
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- University Hospital, Akershus
- Diseases
- Heart failure, Metastatic breast cancer
- NCT number
- NCT05732051
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 16 Mar 2023 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Acute myocardial infarction within the last three months
- 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
- Known allergy to any of the components in the Nicotinamide Riboside (Niagen®) tablet
Age
- Age \<18 years
Other
- Life expectancy \< 6 months
- Contraindications or inability to undergo CMR examination
Who the study is looking for
- Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
- Eastern Cooperative Oncology Group performance status 0-2
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akershus University Hospital Coordinator of this site? Confirm its status | Lørenskog | Norway | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.