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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

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

Awards & highlights

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have nerve damage not caused by chemotherapy.

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My ovarian or endometrial cancer has come back.

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I manage my diabetes with medication.

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I am HIV positive.

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I am taking medication for nerve pain in my hands and feet.

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I need enzyme supplements for my pancreas to work properly.

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I have a digestive condition that affects how I absorb B vitamins.

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I have a bleeding disorder.

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

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

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

460 Previous Clinical Trials

891,786 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

~4 spots leftby Feb 2025

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