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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether nicotinamide riboside, a type of vitamin B3, can reduce nerve pain and tingling experienced after chemotherapy. It targets cancer survivors who completed chemotherapy with specific drugs (taxane or platinum-based) between 1 and 12 months ago. Participants should have finished treatment for certain cancers, such as breast or ovarian, and continue to experience nerve issues. The trial involves taking either the vitamin supplement or a placebo for 84 days. Those who have undergone chemotherapy and still face nerve problems might find this trial suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from an innovative approach to managing nerve pain.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking certain medications, such as duloxetine or other drugs for treating peripheral neuropathy, and any supplements containing nicotinamide riboside, at least 30 days before joining the trial.

Is there any evidence suggesting that nicotinamide riboside is likely to be safe for humans?

Research has shown that nicotinamide riboside (NR) is generally safe for people. Studies have found that NR might help prevent nerve damage caused by chemotherapy drugs like cisplatin and paclitaxel. This suggests it could alleviate the tingling or numbness some patients experience after chemotherapy.

In earlier studies, researchers administered NR to patients to assess its effect on nerve problems. These studies did not identify any major safety concerns, indicating that side effects might be mild or rare. Since this is a phase 2 trial, researchers already have evidence from earlier research suggesting the treatment is likely safe. Phase 2 trials usually focus more on the treatment's effectiveness but still closely monitor safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for peripheral neuropathy?

Researchers are excited about Nicotinamide Riboside for chemotherapy-induced peripheral neuropathy because it offers a novel approach by boosting cellular energy production. Unlike standard treatments like gabapentin or duloxetine, which mainly focus on symptom relief, Nicotinamide Riboside works at a cellular level by enhancing the body's natural repair mechanisms. This active ingredient could potentially protect and repair nerve cells damaged by chemotherapy, offering hope for more effective long-term relief.

What evidence suggests that nicotinamide riboside might be an effective treatment for chemotherapy-induced peripheral neuropathy?

Research suggests that nicotinamide riboside (NR), a type of vitamin B3, might help with nerve problems caused by chemotherapy. Studies in mice have shown that NR can reduce nerve damage from chemotherapy drugs like paclitaxel and cisplatin. This benefit is linked to its ability to increase NAD+ levels, a molecule important for maintaining cell health. Although most evidence comes from animal studies, these findings indicate that NR might also relieve nerve pain and discomfort in humans. In this trial, participants will receive either NR or placebo capsules to further investigate its potential benefits in humans. More research is needed to confirm these results in people. ^{1 3 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04112641

NIAGEN and Persistent Chemotherapy-Induced Peripheral ... The purpose of this randomized, double-blind, placebo-controlled, parallel group phase II trial is to determine whether nicotinamide riboside (NIAGEN®, NR) can ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7508763/

Nicotinamide riboside relieves paclitaxel-induced ... Nicotinamide riboside (NR) is a vitamin B3 precursor of NAD+ that blunts diabetic and chemotherapy-induced peripheral neuropathy in preclinical models.

3. prevention.cancer.gov prevention.cancer.gov/funding-and-grants/funded-grants/R21CA208968

Funded Grants | Division of Cancer Prevention Phase II Trial of Nicotinamide Riboside for Relief of Taxane-Induced Sensory Neuropathy. Chemotherapy is frequently accompanied by peripheral neuropathies so ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03642990

NR in Chemo-induced Peripheral Neuropathy The purpose of this single-arm phase II trial is to determine whether nicotinamide riboside (NIAGEN®) prevents the progression of peripheral sensory neuropathy.

5. redjournal.org redjournal.org/article/S0360-3016(22)02863-2/abstract

Nicotinamide Riboside Alleviates Cisplatin-Induced ... We show that NR, an NAD+ precursor and pharmacologic activator of SIRT2, effectively prevents and alleviates CIPN in mice. We present in vitro ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297957/

Nicotinamide riboside alleviates cisplatin-induced peripheral ... This is the first study demonstrating that nicotinamide riboside can prevent and treat cisplatin-induced neurotoxicity through SIRT2 activation.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0041008X24002643

Nicotinamide riboside activates SIRT3 to prevent paclitaxel ... This study found for the first time that activating SIRT3 helps to improve paclitaxel-induced CIPN. Nicotinamide riboside (NR) can protect dorsal root ganglion ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7352172/

Nicotinamide Riboside—The Current State of Research and ... Furthermore, orally administered NR was found to improve resistance to and reversal of chemotherapeutic neuropathy [159].