NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

NCT04112641 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 201909843
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

peripheral neuropathy; chemotherapy; taxane; platinum compound

Outcome Measures

Primary Outcomes (2)

• Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)

  Change in score from baseline to end of treatment at 84 days. The Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy (20 questions) or QLQ-CIPN20 yields scores of 1-4 (Likert scale) for 9 sensory, 8 motor, and 3 autonomic sequelae of chemotherapy. The minimum score for the sensory subscale is 9 and the maximum possible score is 36. The higher the score, the worse the signs and symptoms. The raw score can, at the investigator's discretion, be linearly transformed to a 0-100 scale, where higher numbers represent worse symptoms. Recent publications call the validity of the autonomic scale into question, and it is not being used in this study.

  84 days

• Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20)

  Change in score from baseline to end of treatment at 84 days. The Quality of Life Questionnaire for Chemotherapy-induced Peripheral Neuropathy (20 questions) or QLQ-CIPN20 yields scores of 1-4 (Likert scale) for 9 sensory, 8 motor, and 3 autonomic sequelae of chemotherapy. The minimum score for the motor subscale is 8 and the maximum possible score is 32. The higher the score, the worse the signs and symptoms. The raw score can, at the investigator's discretion, be linearly transformed to a 0-100 scale, where higher numbers represent worse symptoms. Recent publications call the validity of the autonomic scale into question, and it is not being used in this study.

  84 days

Secondary Outcomes (2)

• Total Neuropathy Score - clinical questionnaire

  84 days

• Intraepidermal Nerve Fiber Density

  84 days

Study Arms (2)

Placebo capsules

PLACEBO COMPARATOR

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

Drug: Placebo capsules

Nicotinamide Riboside (NIAGEN)

EXPERIMENTAL

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.

Drug: Nicotinamide riboside

Interventions

Nicotinamide riboside DRUG

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.

Also known as: NIAGEN

Nicotinamide Riboside (NIAGEN)

Placebo capsules DRUG

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

Also known as: Placebo

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent and HIPAA authorization
• Be ≥ 18 and ≤ 85 years of age
• Have received chemotherapy with taxane (e.g. paclitaxel, nab-paclitaxel, or docetaxol) or platinum-complex (e.g. oxaliplatin, carboplatin, or cisplatin) (alone or in combination) and completed therapy no sooner than 1 month and no later than 1 year earlier.
• Have been treated with above compounds for head and neck cancer, small cell lung cancer, sarcoma, ovarian cancer, endometrial cancer, colorectal cancer, or breast cancer and been declared to have no visible evidence of disease.
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Able to take medication orally - up to four capsules in the morning (am) and four capsules in the evening (pm).
• Be determined to have a raw score of ≥ 12 on the sensory subscale or ≥ 11 on the motor subscale of the QLQ-CIPN20 questionnaire.
• Females must be either postmenopausal for at least 1 year or surgically sterile for at least 6 weeks. Females of childbearing potential must have a negative pregnancy test at screening to be eligible for study participation and agree to take appropriate precautions to avoid pregnancy from screening through follow-up.
• Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up. The following methods have been determined to be more than 99% effective (\<1% failure rate per year when used consistently and correctly) \[69\] and are permitted under this protocol for use by the patient and his/her partner:
• Complete abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the patient
• Double barrier methods
• Condom with spermicide in conjunction with use of an intrauterine device
• Condom with spermicide in conjunction with use of a diaphragm
• Surgical sterilization (bilateral oophorectomy with or without hysterectomy, tubal ligation or vasectomy) at least 6 weeks prior to taking study treatment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), and/or estradiol
• Non-hormonal intrauterine device used as directed by provider placing this is also acceptable.

You may not qualify if:

• Pre-existent peripheral neuropathy that is unrelated to chemotherapy
• Recurrent ovarian or endometrial cancer
• Diabetes managed by medication
• Neutrophils \< 1,000 cells/m3
• Hemoglobin \< 8.0 g/dcl
• Platelets \< 100,000 cells/m3
• Creatinine clearance \< 30 ml/min
• aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values \> 2.5 X upper limits of normal
• Total bilirubin \> 2.0 X upper limits of normal
• Heavy alcohol use defined at \> 8 drinks/week by women or 12 drinks/week by men
• Psychiatric illness that, in the opinion of the investigator, would interfere with the ability of the individual to participate in or complete the study.
• Pregnancy
• Current imprisonment
• Limitations of self-expression, defined as an inability to answer questions posed by physicians, nurses, care-givers, or other members of the investigative team or an inability to describe somatosensations.
• Known HIV

Sponsors & Collaborators

• Donna Hammond, PhD: lead

Study Sites (1)

Donna Hammond

Iowa City, Iowa, 52245, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

nicotinamide-beta-riboside

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Mohammed Milhem, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Donna Hammond, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Michael Shy, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Placebo capsules and drug capsules look alike
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Two independent treatment arms to which patients will be randomized by variable size blocks

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: February 19, 2020
• Primary Completion (Estimated): June 28, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)