← Human Trials & Peer-Reviewed Studies

Pharmacokinetics of nicotinamide in cancer patients treated with accelerated radiotherapy: the experience of the Co-operative Group of Radiotherapy of the European Organization for Research and Treatment of Cancer.

Plain-language guide to PMID 9783883 (1998): phase 2 clinical trial of NAD+ in 15 patients.

Key Facts

PMID
9783883
Journal
Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology
Year
1998
Study type
Clinical Trial, Phase II
Authors
Bernier J et al. (9 authors)
DOI
10.1016/s0167-8140(98)00048-6

What This Study Did, in Plain Language

What Was Tested

The paper reports a study of NAD+, published as a phase 2 clinical trial.

The EORTC has initiated studies to combine nicotinamide with carbogen in accelerated fractionation schedules (ARCON), since for some tumour types, acute and chronic hypoxia as well as treatment protraction may prejudice the outcome of radiotherapy.

Who Took Part

The study group was 15 patients.

Nicotinamide (Nicobion) was administered in tablet form to patients with advanced head and neck and non-small cell lung carcinomas.

In 15 patients, blood samples were taken prior to and 1, 2, 4, 6, 8, 12 and 24 h after administration of the drug.

How the Study Was Run

This full profile was determined on two to four occasions for the head and neck cancer patients and on two occasions for the lung cancer patients.

For each profile, the maximum concentration of nicotinamide (Cmax), time to peak plasma concentration (Tmax), elimination half-lives (t1/2) and area under the curve (AUC) were determined.

Compliance was recorded and nausea and vomiting were graded on a 0-3 scale.

Complete profiles of the five major metabolites were also obtained.

What Was Measured

The EORTC has initiated studies to combine nicotinamide with carbogen in accelerated fractionation schedules (ARCON), since for some tumour types, acute and chronic hypoxia as well as treatment protraction may prejudice the outcome of radiotherapy.

PubMed files the paper under topics including Area Under Curve, Carbon Dioxide, Carcinoma, Carcinoma, Non-Small-Cell Lung, Cell Hypoxia, Half-Life and Head and Neck Neoplasms.

What This Means in Plain Language

This is a phase 2 clinical trial of NAD+ in 15 patients.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

Its findings take up roughly 7 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 1998 (Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology), a journal based in Ireland.

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

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: PubMed record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.