NCT06617182

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.

Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Yongquan Shi · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

At present, there is still a lack of standard and effective treatment strategies and procedures for radiation intestinal injury. Studies have shown that thalidomide can effectively treat refractory gastrointestinal bleeding caused by vascular malformation. Therefore, The investigators designed a single-center, open-label, randomized controlled study to evaluate the efficacy and safety of thalidomide combined with glutamine in the treatment of radiation intestinal injury.

Detailed description

Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form. Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks. Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.

Conditions

• Radiation Enteritis

Interventions

Type	Name	Description
DRUG	Thalidomide	Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.
DRUG	Glutamine	In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks.
DRUG	Thalidomide+Glutamine	Patients in thalidomide combined with glutamine group took thalidomide orally at a dose of 100mg once a day and two capsules of glutamine were taken orally 3 times a day for 8 weeks.

Timeline

• Start date: 2024-09-30
• Primary completion: 2028-10-01
• Completion: 2028-11-01
• First posted: 2024-09-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: China