Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis

Summary

The goal of this clinical research study is to learn if glutamine can help control and prevent sores, blisters, or inflammation in your mouth or esophagus due to your current treatment. In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks like the drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Timeline

Start

2014-07-10

Primary completion

2021-03-03

Completion

2021-03-03

Outcome

Missed primary endpoint

Stopped: “Per PI”

registry analysis (other test); Radiation Therapy to Esophagus Patient Group - Glutamine vs Radiation Therapy to Esophagus Patient Group - Placebo; p = 0.73; Wilcoxon (Mann-Whitney) NCT01952847 ↗

registry analysis (other test); mTOR Inhibitor Patient Group - Glutamine vs mTOR Inhibitor Patient Group - Placebo; p = 0.68; Wilcoxon (Mann-Whitney) NCT01952847 ↗

paper There was no difference in the incidence of esophagitis in the first 6 weeks of radiotherapy between the glutamine and placebo arms (74% versus 68%; P = 1.00). PMID 33580845 ↗

Publications

• Alshawa A, Cadena AP, Stephen B, Reddy A, Mendoza TR, McQuinn L, Lawhorn K, Zarifa A, Bernhardt AM, Fessaheye S, Warneke CL, Chang JY, Naing A. Effects of glutamine for prevention of radiation-induced esophagitis: a double-blind placebo-controlled trial. Invest New Drugs. 2021 Aug;39(4):1113-1122. doi: 10.1007/s10637-021-01074-w. Epub 2021 Feb 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glutamine	Other / unclassified	4 g	Oral

Indications