Nicotinamide Riboside for Chemotherapy-Induced Peripheral Neuropathy

Overseen By Spenser Pfannenstiel, B.S.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Iowa

Must not be taking: Nicotinamide riboside, Duloxetine

Disqualifiers: Diabetes, Heavy alcohol use, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

48 Participants Needed

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

Donna Hammond, Ph.D.

Principal Investigator

University of Iowa

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

Exclusion Criteria

Heavy alcohol use

Psychiatric illness that would interfere with study participation

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either placebo or NIAGEN capsules daily for 84 days, with regular assessments and biomarker measurements

12 weeks

6 visits (in-person) every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with all measures conducted again to assess persistence of alleviation

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• Nicotinamide Riboside

Trial Overview 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.

Participant Groups

Group I: Nicotinamide Riboside (NIAGEN) Experimental Treatment 1 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 capsules Placebo Group 1 Intervention

Subjects will take 2 capsules in the a.m. and 2 capsules in the p.m. daily for 84 days.

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+