Trial Title:
Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
NCT ID:
NCT05732051
Condition:
Breast Cancer
Metastatic Breast Cancer
Cancer Therapy-Related Cardiac Dysfunction
Cardiotoxicity
Heart Failure
Conditions: Official terms:
Breast Neoplasms
Cardiotoxicity
Niacinamide
Niacin
Nicotinic Acids
Conditions: Keywords:
Breast Cancer
Anthracyclines
Niagen
Nicotinamide riboside
Nicotinamide adenine dinucleotide
Reactive oxygen species
Cardiac Dysfunction
Cardio-oncology
Cardiotoxicity
Cancer Therapy-Related Cardiac Dysfunction
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Double-blind, randomised, placebo-controlled
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
The IMP and matching placebos will be provided by the manufacturers of ChromaDex. The
Data Safety Committee will have the treatment allocation list.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Nicotinamide Riboside
Description:
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline
therapy
Arm group label:
Treatment Arm
Other name:
Niagen (serial number 85932490, registration number 4606519)
Intervention type:
Dietary Supplement
Intervention name:
Placebo
Description:
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
Arm group label:
Placebo Control Arm
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.
Detailed description:
The trial is prospective, randomised, double-blind and placebo-controlled. The primary
objective is change in left ventricular ejection fraction (LVEF), determined by cardiac
MRI (CMR). Secondary objectives are change in circulating high-sensitivity cardiac
troponin I and T (hs-TnI and hs-TnT), Creatine Kinase (CK) and myoglobin, and various
measurements of change in left ventricular systolic function determined by CMR and
echocardiography. Additional assessments are evaluation of the patient's functional
capacity and the patients will be asked to fill out questionnaires to assess quality of
life.
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Akershus University Hospital
Address:
City:
Lørenskog
Zip:
1478
Country:
Norway
Status:
Recruiting
Contact:
Last name:
Torbjørn Omland, MD, PhD
Phone:
+47 40107050
Email:
torbjorn.omland@medisin.uio.no
Contact backup:
Last name:
Victoria Vinje, MD
Phone:
+47 92033665
Email:
victoria.vinje@ahus.no
Investigator:
Last name:
Torbjørn Omland, MD, PhD
Email:
Principal Investigator
Investigator:
Last name:
Jürgen Geisler, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Evandro F Fang, PhD
Email:
Sub-Investigator
Start date:
March 16, 2023
Completion date:
September 30, 2035
Lead sponsor:
Agency:
University Hospital, Akershus
Agency class:
Other
Collaborator:
Agency:
ChromaDex, Inc.
Agency class:
Industry
Collaborator:
Agency:
Norwegian Cancer Society
Agency class:
Other
Collaborator:
Agency:
Norwegian Breast Cancer Association
Agency class:
Other
Collaborator:
Agency:
Helse Sor-Ost
Agency class:
Other
Source:
University Hospital, Akershus
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05732051
