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NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

NCT04112641 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-07-30

No results posted yet for this study

Summary

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.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DRUG

Nicotinamide riboside

Daily oral ingestion of 1 g/day NIAGEN in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m.

DRUG

Placebo capsules

Daily oral ingestion of placebo in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m.

Sponsors & Collaborators

  • Donna Hammond, PhD

    lead OTHER

Principal Investigators

  • Mohammed Milhem, M.D. · University of Iowa

  • Donna Hammond, Ph.D. · University of Iowa

  • Michael Shy, M.D. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2026-06-28
Completion
2026-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112641 on ClinicalTrials.gov