← Back to Search

Nicotinamide Riboside for Chemotherapy-Induced Peripheral Neuropathy

Phase 2
Waitlist Available
Led By Laurie Guttmann, M.D.
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be ≥ 18 and ≤ 85 years of age
Have been treated with above compounds for specific types of cancer and declared to have no visible evidence of disease
Must not have
Pre-existent peripheral neuropathy that is unrelated to chemotherapy
Recurrent ovarian or endometrial cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 84 days

Summary

This trial is testing whether a compound called nicotinamide riboside can help improve symptoms of nerve damage in cancer survivors who have completed chemotherapy.

Who is the study for?
This trial is for cancer survivors aged 18-85 who finished chemotherapy with taxane or platinum compounds between 1 month and a year ago, have no visible disease now, can take oral medication, and are experiencing persistent peripheral neuropathy. Women must meet certain reproductive criteria; men must avoid fathering children during the study.
What is being tested?
The trial tests if Nicotinamide riboside (NIAGEN) can relieve long-lasting nerve pain caused by chemotherapy in cancer survivors. Participants will be randomly assigned to receive either NIAGEN or placebo capsules without knowing which one they're getting.
What are the potential side effects?
While specific side effects of NIAGEN aren't listed here, common ones may include upset stomach, diarrhea, nausea, fatigue. Placebos typically have no active ingredients but can cause similar symptoms due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 85 years old.
Select...
I was treated for cancer and currently show no signs of the disease.
Select...
I am able to care for myself and perform daily activities.
Select...
I can take up to eight capsules daily by mouth.
Select...
I agree to use contraception to prevent pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have nerve damage not caused by chemotherapy.
Select...
My ovarian or endometrial cancer has come back.
Select...
I manage my diabetes with medication.
Select...
I am HIV positive.
Select...
I am taking medication for nerve pain in my hands and feet.
Select...
I need enzyme supplements for my pancreas to work properly.
Select...
I have a digestive condition that affects how I absorb B vitamins.
Select...
I have a bleeding disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~84 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 84 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)
Secondary study objectives
Intraepidermal Nerve Fiber Density
Total Neuropathy Score - clinical questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nicotinamide Riboside (NIAGEN)Experimental Treatment1 Intervention
Subjects will take 2 250-mg capsules in the a.m. and 2 250- mg capsules in the p.m. daily (total daily dose is 1 g) for 84 days.
Group II: Placebo capsulesPlacebo Group1 Intervention
Subjects will take 2 capsules in the a.m. and 2 capsules in the p.m. daily for 84 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotinamide riboside
2021
Completed Phase 3
~390

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor
467 Previous Clinical Trials
893,423 Total Patients Enrolled
Donna Hammond, PhDLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Laurie Guttmann, M.D.Principal InvestigatorUniversity of Iowa

Media Library

Nicotinamide riboside Clinical Trial Eligibility Overview. Trial Name: NCT04112641 — Phase 2
Peripheral Neuropathy Research Study Groups: Nicotinamide Riboside (NIAGEN), Placebo capsules
Peripheral Neuropathy Clinical Trial 2023: Nicotinamide riboside Highlights & Side Effects. Trial Name: NCT04112641 — Phase 2
Nicotinamide riboside 2023 Treatment Timeline for Medical Study. Trial Name: NCT04112641 — Phase 2
~2 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top