NCT04112641

NIAGEN and Persistent Chemotherapy-Induced Peripheral Neuropathy

Alleviation by NIAGEN of Persistent Chemotherapy-Induced Peripheral Neuropathy in Cancer Survivors

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Donna Hammond, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Subjects will be asked to return every two weeks to complete the questionnaires, and blood will be drawn to measure biomarkers of NIAGEN consumption. Blood will be drawn at visits on days 28, 56, and 84 for clinical chemistries and measures of liver and kidney function. At visits on day 42 and 84, additional measures of density of nerve fibers in the hand and leg will be made. The last treatment day will be day 84, at which time all measures will be redetermined. A follow-up period of 3 months is planned at which time all measures will be conducted once again to determine if any alleviation of the chemotherapy has persisted after treatment ended. Patients enrolled in this study will receive standard of care treatment by their oncologists, which includes computed tomography, magnetic resonance or ultrasound scans every three months as surveillance for cancer re-occurrence.

Conditions

• Chemotherapy-induced Peripheral Neuropathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-19
• Primary completion: 2026-06-28
• Completion: 2026-07-01
• First posted: 2019-10-02
• Last updated: 2025-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study