Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
NCT ID: NCT05732051
Last Updated: 2023-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2023-03-16
2035-09-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Treatment Arm
The patients randomised into this arm of the trial will receive 500 mg Nicotinamide Riboside b.i.d. The duration of blinded therapy will depend on the duration of anthracycline therapy, and will for some patients last for 3 months, others for 6 months.
Nicotinamide Riboside
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
Placebo Control Arm
The patients randomised into this arm of the trial will receive a matching placebo b.i.d. The duration of treatment is equivalent to the description in the treatment arm.
Placebo
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Interventions
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Nicotinamide Riboside
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
Placebo
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group performance status 0-2
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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ChromaDex, Inc.
INDUSTRY
Norwegian Cancer Society
OTHER
Norwegian Breast Cancer Association
UNKNOWN
Helse Sor-Ost
OTHER_GOV
University Hospital, Akershus
OTHER
Responsible Party
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Torbjorn Omland
Professor
Principal Investigators
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Torbjørn Omland, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Akershus
Locations
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Akershus University Hospital
Lørenskog, Akershus, Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021/156064(REK)
Identifier Type: -
Identifier Source: org_study_id
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