Breast CancerPhase 2NARNIANCT05732051
Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
A Phase 2 study testing Nicotinamide Riboside in people with Breast Cancer and Metastatic Breast Cancer, run by University Hospital, Akershus at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer, Cancer Therapy-Related Cardiac Dysfunction
- What is being tested?
- Nicotinamide Riboside
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 16 Mar 2023to 30 Sep 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
- Eastern Cooperative Oncology Group performance status 0-2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Akershus University Hospital
Lørenskog, Akershus, 1478
Torbjørn Omland, MD, PhD, +47 40107050, torbjorn.omland@medisin.uio.no
Victoria Vinje, MD, +47 92033665, victoria.vinje@ahus.no
About this study
Official title: Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines
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.
Read the 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.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Cancer Therapy-Related Cardiac Dysfunction, Cardiotoxicity, Heart Failure
- Being tested
- Nicotinamide Riboside, Placebo
- Keywords
- Breast Cancer, Anthracyclines, Niagen, Nicotinamide riboside, Nicotinamide adenine dinucleotide, Reactive oxygen species, Cardiac Dysfunction, Cardio-oncology, Cardiotoxicity, Cancer Therapy-Related Cardiac Dysfunction
- Medical subject headings
- Breast Neoplasms, Cardiotoxicity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide RibosideDietary supplement
Also called Niagen (serial number 85932490, registration number 4606519)
Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy
PlaceboDietary supplement
Matching placebo b.i.d as long as the patient is receiving anthracycline therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Active comparator | 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. Receives: Dietary Supplement: Nicotinamide Riboside |
| Placebo Control Arm | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether the administration of nicotinamide riboside can prevent the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR), compared to placebo.
Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy.
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Secondary outcomes (8)
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography
From randomization to the end of blinded therapy:
Change in LVEF, as determined by echocardiography
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography
From randomization to the end of blinded therapy:
Change in left ventricular global longitudinal strain (GLS), as determined by echocardiography
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR
From randomization to the end of blinded therapy:
Change in left ventricular global circumferential strain (GCS) and GLS, as determined by CMR
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR
From randomization to the end of blinded therapy:
Change in left ventricular end-systolic volume measured by CMR
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin T (hs-cTnT)
From randomization to the end of blinded therapy:
Change in circulating hs-cTnT
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin I (hs-cTnI)
From randomization to the end of blinded therapy:
Change in circulating hs-cTnI
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity
From randomization to the end of blinded therapy:
Change in distance in meters during 6-minute walk test
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity
From randomization to the end of blinded therapy:
Change in force generated by handgrip strength test
Measured: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start16 Mar 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion30 Sep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomised, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- ChromaDex, Inc., Norwegian Cancer Society, Norwegian Breast Cancer Association, Helse Sor-Ost
- Responsible party
- Principal investigator, Torbjorn Omland, University Hospital, Akershus
- Investigators
- Torbjørn Omland, MD, PhD, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732051
- Sponsor's protocol ID
- 2021/156064(REK)
- Acronym
- NARNIA
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nicotinamide Riboside on Myocardial and Skeletal Muscle Injury and Function in Patients With Metastatic Breast Cancer Receiving Anthracyclines
- ClinicalTrials.gov ID
- NCT05732051
- Acronym / sponsor ID
- NARNIA / 2021/156064(REK)
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Cancer Therapy-Related Cardiac Dysfunction, Cardiotoxicity, Heart Failure
- Keywords
- Breast Cancer, Anthracyclines, Niagen, Nicotinamide riboside, Nicotinamide adenine dinucleotide, Reactive oxygen species, Cardiac Dysfunction, Cardio-oncology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- ChromaDex, Inc., Norwegian Cancer Society, Norwegian Breast Cancer Association, Helse Sor-Ost
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 30 Sep 2035 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomised, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Dietary Supplement: Nicotinamide RibosideThe 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. |
| Placebo Control Arm | Placebo comparator | Dietary Supplement: PlaceboThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women with metastatic breast cancer (stage IV breast cancer) scheduled for anthracycline-containing chemotherapy
- Eastern Cooperative Oncology Group performance status 0-2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotinamide RibosideAlso: Niagen (serial number 85932490, registration number 4606519)Nicotinamide Riboside 500mg b.i.d as long as the patient is receiving anthracycline therapy | Dietary supplement | Treatment Arm |
| PlaceboMatching placebo b.i.d as long as the patient is receiving anthracycline therapy | Dietary supplement | Placebo Control Arm |
Primary outcome
Whether the administration of nicotinamide riboside can prevent the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR), compared to placebo.
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Change in left ventricular ejection fraction (LVEF), as determined by CMR from randomization to end of blinded therapy.
8 secondary outcomes
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by echocardiography
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Assess whether the administration of nicotinamide riboside is associated with less reduction in left ventricular systolic function measured by CMR
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin T (hs-cTnT)
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less myocardial injury measured by high-sensitive cardiac troponin I (hs-cTnI)
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
To assess whether the administration of nicotinamide riboside is associated with less worsening in functional capacity
Time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Torbjørn Omland, MD, PhD principal investigator
University Hospital, Akershus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinamide Riboside in people with Breast Cancer and Metastatic Breast Cancer, run by University Hospital, Akershus at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Torbjørn Omland, MD, PhD (+47 40107050, torbjorn.omland@medisin.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether the administration of nicotinamide riboside can prevent the reduction in left ventricular systolic function measured by cardiovascular magnetic resonance (CMR), compared to placebo. (time frame: Baseline, 3 months, 6 months for patients receiving extended chemotherapy, and extended follow up 12 months after initiation of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.