NR in Chemo-induced Peripheral Neuropathy

What Was Tested

The trial (phase 2) is built around NAD+ for endometriosis.

It had 1 arm (groups): NIAGEN®) (experimental).

The registry classes the interventions as drug.

More on the Plan

CIPN can seriously diminish a patient's quality of life, and can interfere with self-care and activities of daily living.

Nicotinamide adenine dinucleotide (NAD+) is an essential redox coenzyme required for cell viability, basic bioenergetics, and fast axonal transport (Yang and Sauve, 2016).

It plays an important role in protection against axonal injury from either mechanical or neurotoxic injury (Araki et al., 2004; Sasaki et al., 2006; Sasaki et al., 2009; Gerdts et al., 2015; Khan et al., 2014; Conforti et al., 2014; Di Stefano et al., 2015).

Nicotinamide riboside (NIAGEN®) is a form of vitamin B3 and a precursor in the pathway for synthesis of NAD+ (Bieganowski et al., 2004; Trammell et al., 2016; Chi and Sauve, 2013).

Who Took Part

5 actual participants took part.

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 to 85 years old. Have an 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). Complete abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the patient.

The full record lists 11 inclusion and 26 exclusion criteria; among the exclusions: pre-existent peripheral neuropathy that is unrelated to chemotherapy; pre-existent chemotherapy-induced peripheral neuropathy greater than grade 2; known metastases to the brain, spinal cord or peripheral nerves, or leptomeningeal disease.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label NAD+ study: the endometriosis participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-11-08 with completion listed for 2021-08-18.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants With No Worsening in the Grade of Peripheral Sensory Neuropathy as Scored by CTCAE (time frame: approximately 4 weeks).

It also tracked 4 secondary outcomes, for example Difference in Score Between Baseline and End of Treatment for the FACT&GOG-NTX Subscale .

What This Means in Plain Language

Put simply, this is a phase 2 trial of NAD+ in 5 people with endometriosis.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the NAD+ compound page, Endometriosis research.