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Clinical Trial Summary

Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

Clinical Trial Description

Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05059613
Study type Interventional
Source Jiangxi Provincial Cancer Hospital
Contact Chunling Jiang, MD PHD
Phone 13979109200
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 20, 2021
Completion date December 31, 2022

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