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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 84 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am between 18 and 85 years old.

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I was treated for cancer and currently show no signs of the disease.

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I am able to care for myself and perform daily activities.

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I can take up to eight capsules daily by mouth.

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I agree to use contraception to prevent pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 84 days

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

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

Primary outcome measures

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 outcome measures

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

~400

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

446 Previous Clinical Trials

879,454 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

Frequently Asked Questions

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

Is this medical research currently accepting participants?

"Per the information displayed on clinicaltrials.gov, this medical trial has been open for recruitment since 2/19/2020 and was last updated on 1/24/2022."

Answered by AI

Are senior citizens eligible to join this clinical experiment?

"This clinical trial requires that participants are between 18 to 85 years of age. A separate 5 studies have been set up for those under the legal age, while 171 trials exist for people over 65."

Answered by AI

Has the FDA sanctioned Nicotinamide riboside for use?

"Our team at Power assigned Nicotinamide riboside a risk score of 2, since preliminary safety data exists but efficacy is yet to be tested."

Answered by AI

How many individuals are being administered care in this trial?

"Affirmative. Clinicaltrials.gov records show that this clinical trial is actively enrolling, having first been posted on February 19th 2020 and last updated January 24th 2022. The study requires 48 patients from a single site to participate."

Answered by AI

Who meets the eligibility criteria necessary to take part in this clinical trial?

"This medical trial has a capacity of 48 participants who suffer from peripheral nervous system maladies, ranging in age from 18 to 85. Furthermore, the following criteria must be met for eligibility: having received chemotherapy with taxane or platinum-complex at least one month and no more than a year prior; abstaining from sexual intercourse if it is consistent with their lifestyle; scoring 12 on sensory subscale/11 motor subscale on QLQ-CIPN20 questionnaire; postmenopausal females must have been so for 1+ years and fertile women require a negative pregnancy test as well as double barrier contraception methods; lastly, an ECOG"

Answered by AI

Which experiments have been conducted featuring Nicotinamide riboside?

"Currently, there are 15 trials examining the efficacy of Nicotinamide riboside and one study has reached Phase 3. Most studies on this drug are situated in Winston-Salem, North carolina; however 19 locations have active research projects involving Nicotinamide riboside."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

Donna Hammond, PhD 2020. "NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04112641.

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