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Nicotinamide Riboside and Prevention of Cancer Therapy Related Cardiac Dysfunction in Breast Cancer Patients
Plain-language guide to NCT05732051: phase 2 randomized trial of NAD+, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05732051
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2023-03-16
- Completion (planned or actual)
- 2025-08-01
- Participants
- 60 (estimated)
- Design
- randomized, quadruple-blind, prevention
- Conditions studied
- Breast Cancer; Metastatic Breast Cancer; Cancer Therapy-Related Cardiac Dysfunction; Cardiotoxicity; Heart Failure
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test NAD+.
It had two arms (groups): Treatment Arm (active comparator) and 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.
The registry classes the interventions as dietary supplement.
More on the Plan
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.
Who Took Part
60 planned participants were the target.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Eastern Cooperative Oncology Group performance status 0-2.
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: age \<18 years; acute myocardial infarction within the last three months; life expectancy \< 6 months.
How the Study Was Run
It was run as a randomized, parallel-group and quadruple-blind study.
Because people in this NAD+ study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2023-03-16 with completion listed for 2025-08-01.
It ran at 1 site in Norway.
Its stated primary purpose is prevention.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of NAD+ in 60 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NAD+ compound page, all human trials.
Our Notes on the Compound
NAD+: The coenzyme that accepts electrons at complex I.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.