NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

What Was Tested

In this phase 2 trial, researchers set out to test NAD+.

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.

It had two arms (groups): Placebo capsules (placebo comparator) and Nicotinamide Riboside (NIAGEN) (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients who have been declared to be in complete remission after treatment of their cancer with either taxane or platinum-based compounds and who have persistent neuropathy will be randomized to receive either placebo or NIAGEN capsules daily for 84 days.

On enrollment, subjects will complete several questionnaires characterizing the type and severity of their neuropathy.

Their fifth finger will be scanned to determine the density of sensory afferents in the skin, and a skin biopsy will be taken above the ankle for histological analysis of nerve fiber density.

Blood samples will be drawn for baseline measures of NAD+ levels, and clinical chemistries and indices of liver and kidney function.

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 18 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Be able to give written informed consent and HIPAA authorization. Be ≥ 18 and ≤ 85 years of age. 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.

The full record lists 15 inclusion and 22 exclusion criteria; among the exclusions: pre-existent peripheral neuropathy that is unrelated to chemotherapy; recurrent ovarian or endometrial cancer; diabetes managed by medication.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

The NAD+ group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received NAD+.

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2020-02-19 with completion listed for 2027-06-28.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Score on Sensory Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20) (time frame: 84 days). Score on Motor Subscale of Quality of Life Questionnaire Chemotherapy-induced Peripheral Neuropathy (QLQ-CIPN20) (time frame: 84 days).

It also tracked 2 secondary outcomes, for example Total Neuropathy Score - clinical questionnaire and Intraepidermal Nerve Fiber Density.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of NAD+ in 48 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.