NCT06031012

Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Air Force Military Medical University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to compare glutamine combined with thalidomide with glutamine in preventing radiation-induced oral mucositis. The aim of this study is to answer whether glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis. Participants would be randomly divided into the two groups above mentioned.

Detailed description

Explore the therapeutic efficacy of glutamine combined with Thalidomide as compared to glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint is the median time to the onset of Grade II oral mucositis, defined as the number of days from the start of radiation therapy to the occurrence of Grade II oral mucositis.

Conditions

• Mucositis Oral

Interventions

Type	Name	Description
DRUG	glutamine combined with thalidomide	Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.
DRUG	glutamine alone	Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.

Timeline

• Start date: 2023-09-15
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2023-09-11
• Last updated: 2026-03-12

Locations

1 site across 1 country: China