← Back to Search

Vitamin

Nicotinamide Riboside for Peripheral Neuropathy

Phase 2

Waitlist Available

Led By Alexandra Thomas, MD

Research Sponsored by Donna Hammond, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

Study Summary

This trial is testing whether a supplement called nicotinamide riboside can help prevent nerve damage in people receiving cancer treatment.

Eligible Conditions

Chemotherapy-induced Peripheral Neuropathy
Head and Neck Cancers
Endometrial Cancer
Ovarian Cancer
Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With No Worsening in the Grade of Peripheral Sensory Neuropathy as Scored by CTCAE

Secondary outcome measures

Difference in Score Between Baseline and End of Treatment for the FACT&GOG-NTX Subscale .

Number of Dose Reduction Events

Percentage of Patients in Which Dose of Paclitaxel or Nab-Paclitaxel is Reduced Due to CIPN

+1 more

Other outcome measures

Difference in Total Neuropathy Score Between Screening and End of Treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: NIAGEN®)Experimental Treatment1 Intervention

Daily oral administration of nicotinamide riboside 300 mg (150 mg a.m. and p.m.) for one week with dose escalation to 1000 mg (500 mg a.m. and p.m.) for remaining 11 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotinamide riboside

Not yet FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Donna Hammond, PhDLead Sponsor

1 Previous Clinical Trials

48 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,662 Total Patients Enrolled

14 Trials studying Peripheral Neuropathy

1,473 Patients Enrolled for Peripheral Neuropathy

ChromaDex, Inc.Industry Sponsor

7 Previous Clinical Trials

393 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this study encompass individuals aged 55 years or older?

"This medical trial is seeking individuals aged 18 and above, but not exceeding 85 years old."

Answered by AI

How many individuals have volunteered to partake in this clinical survey?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, posted to the website on November 8th 2019 and last modified April 26th 2021 is still recruiting patients. The study requires 39 participants from two medical centres."

Answered by AI

Who has the necessary credentials to be included in this research project?

"This medical trial is searching for 39 individuals, aged between 18 and 85 years old, that have chemotherapy-induced peripheral neuropathy. To be eligible to participate in the study participants must meet additional criteria such as: having been diagnosed with stage IV breast cancer of any type; being postmenopausal for at least 1 year or surgically sterile for at least 6 weeks (females); undergoing infusions treatments of paclitaxel/nab-paclitaxel; possessing a performance status ranging 0–2; displaying grade one sensory neuropathy according to CTCAE version 4.03 guidelines; engaging in abstinence from sexual intercourse if"

Answered by AI

Has the FDA sanctioned Nicotinamide Riboside for medical use?

"Though limited data exists for Nicotinamide Riboside's efficacy, there is enough evidence to suggest safety and as such it has been awarded a score of 2."

Answered by AI

Could you outline the findings of past research on Nicotinamide Riboside?

"At the current moment, there is a single Phase 3 trial for Nicotinamide Riboside with 15 trials in total. Most of these studies are found near Winston-Salem North carolina, however 19 sites across the globe have similar research initiatives."

Answered by AI

Does this research venture currently require additional participants?

"Clinicaltrials.gov indicates that this trial is accepting participants, with the original post on November 8th 2019 and the last update taking place April 26th 2021."

Answered by AI

Recent research and studies

Biochimica et Biophysica Acta (BBA) - Proteins and ProteomicsJournal

NAD + Metabolism: Bioenergetics, Signaling and Manipulation for Therapy

Yang, Yue, and Anthony A. Sauve. 2016. “NAD + Metabolism: Bioenergetics, Signaling and Manipulation for Therapy”. Biochimica Et Biophysica Acta (BBA) - Proteins and Proteomics. Elsevier BV. doi:10.1016/j.bbapap.2016.06.014.

Journal of NeuroscienceJournal

Transgenic Mice Expressing the Nmnat1 Protein Manifest Robust Delay in Axonal Degeneration in Vivo

Sasaki, Y., B. P. S. Vohra, R. H. Baloh, and J. Milbrandt. 2009. “Transgenic Mice Expressing the Nmnat1 Protein Manifest Robust Delay in Axonal Degeneration in Vivo”. Journal of Neuroscience. Society for Neuroscience. doi:10.1523/jneurosci.1429-09.2009.

EMBO Molecular MedicineJournal

Effective Treatment of Mitochondrial Myopathy by Nicotinamide Riboside, a Vitamin <scp>b</scp> 3

Khan, Nahid A, Mari Auranen, Ilse Paetau, Eija Pirinen, Liliya Euro, Saara Forsström, Lotta Pasila, et al.. 2014. “Effective Treatment of Mitochondrial Myopathy by Nicotinamide Riboside, a Vitamin b 3”. EMBO Molecular Medicine. EMBO. doi:10.1002/emmm.201403943.

Plos OneJournal