NCT05059613

Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Jiangxi Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Oral Mucositis
• Quality of Life

Interventions

Type	Name	Description
OTHER	probiotics	one times a day during the whole treatment

Timeline

• Start date: 2021-09-20
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-09-28
• Last updated: 2021-09-28

Locations

1 site across 1 country: China