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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
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 belowSelect...
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:Select...
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
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
471 Previous Clinical Trials
894,613 Total Patients Enrolled
Donna Hammond, PhDLead Sponsor
1 Previous Clinical Trials
5 Total Patients Enrolled
Laurie Guttmann, M.D.Principal InvestigatorUniversity of Iowa
Donna Hammond, Ph.D.Principal InvestigatorUniversity of Iowa
Michael Shy, M.D.Principal InvestigatorUniversity of Iowa
Mohammed Milhem, M.D.Principal InvestigatorUniversity of Iowa
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I am able to care for myself and perform daily activities.I have a digestive condition that affects how I absorb B vitamins.I completed chemotherapy with taxane or platinum between 1 month and 1 year ago.I am a woman who is either post-menopausal, surgically sterile, not pregnant, and using contraception.I have nerve damage not caused by chemotherapy.My ovarian or endometrial cancer has come back.I manage my diabetes with medication.I am taking medication for nerve pain in my hands and feet.I need enzyme supplements for my pancreas to work properly.I have a bleeding disorder.I am between 18 and 85 years old.I was treated for cancer and currently show no signs of the disease.I can take up to eight capsules daily by mouth.I agree to use contraception to prevent pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: Nicotinamide Riboside (NIAGEN)
- Group 2: Placebo capsules
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.