Nicotinamide Riboside for Chemotherapy-Induced Peripheral Neuropathy
DL
MS
SP
Overseen BySpenser Pfannenstiel, B.S.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Iowa
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries
Trial Summary
What is the purpose of this trial?
The purpose of this randomized, double-blind, placebo-controlled, parallel group phase II trial is to determine whether nicotinamide riboside (NIAGEN®, NR) can ameliorate persistent peripheral neuropathy in cancer survivors who have completed chemotherapy with taxane or platinum-complex compounds between 1 and 12 months earlier.
Research Team
Mohammed Milhem, MBBS
Principal Investigator
University of Iowa
DH
Donna Hammond, Ph.D.
Principal Investigator
University of Iowa
MS
Michael Shy, M.D.
Principal Investigator
University of Iowa
Eligibility Criteria
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.Inclusion Criteria
I am able to care for myself and perform daily activities.
Be able to give written informed consent and HIPAA authorization
Be determined to have a raw score of ≥ 12 on the sensory subscale or ≥ 11 on the motor subscale of the QLQ-CIPN20 questionnaire
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Exclusion Criteria
Heavy alcohol use
Psychiatric illness that would interfere with study participation
Pregnancy
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Treatment Details
Interventions
- Nicotinamide Riboside
Trial OverviewThe 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.
Participant Groups
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.
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Who Is Running the Clinical Trial?
University of Iowa
Lead Sponsor
Trials
486
Recruited
934,000+
Donna Hammond, PhD
Lead Sponsor
Trials
2
Recruited
50+
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