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

Phase 2

Not yet recruiting

• Conditions: Radiation Enteritis
• Interventions: Drug: Thalidomide; Drug: Glutamine; Drug: Thalidomide+Glutamine

• Registration Number: NCT06617182
• Lead Sponsor: Yongquan Shi

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Last Update Submitted: 2024-09-26
• Study First Posted: 2024-09-27
• Study Start: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Age 18-80 years old, gender is not limited;
• Patients with hematochezia symptoms of chronic radiation intestinal injury: Due to the lack of diagnostic gold standard for radiation intestinal injury, a comprehensive analysis of clinical, endoscopic, imaging and histopathological findings was mainly performed to make the diagnosis of radiation intestinal injury on the basis of excluding infectious and other non-infectious intestinal injuries. Exposure to radioactive sources is a necessary factor in the diagnosis of radiation intestinal injury, and tumor activity or recurrence should be excluded.
• The proportion of dominant defecation bleeding in total defecation times in the week before treatment is not less than 20%;
• ECOG score: 0-2.

Exclusion Criteria

• Patients with hemodynamic instability;
• Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR<60ml/min or dialysis patients;
• Patients allergic to thalidomide or glutamine;
• Patients whose primary disease was gastrointestinal malignancy;
• Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;
• Female patients during pregnancy and breastfeeding (including patients with reproductive needs);
• Patients infected with HIV;
• Patients who cannot cooperate with regular follow-up and review of laboratory indicators;
• any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The thalidomide group	Thalidomide	Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks.
The glutamine group	Glutamine	Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks.
The thalidomide combined with glutamine group	Thalidomide+Glutamine	Patients in the thalidomide combined with glutamine group will receive oral thalidomide at a dosage of 100 mg one time daily and two enteric-soluble capsules of compound glutamine three times a day for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Treatment response rate.	From enrollment to the end of treatment at 8 weeks.	The proportion of overt defecation bleeding in total defecation within 1 week after treatment was reduced by ≥50% compared with 1 week before treatment.

Secondary Outcome Measures

Name	Time	Method
No further bleeding occurred within 1 week after treatment	From enrollment to the end of treatment at 8 weeks.	Stool occult blood negative 2 times in a row on different dates
Number of blood transfusions during the treatment period	From enrollment to the end of treatment at 8 weeks.	times
Red blood cell input	From enrollment to the end of treatment at 8 weeks.	Input red blood cells according to the situation
Hemoglobin level	From enrollment to the end of treatment at 8 weeks.	Record each test result
Number of hospitalizations due to bleeding	From enrollment to the end of treatment at 8 weeks.	times
Number of days in hospital due to bleeding	From enrollment to the end of treatment at 8 weeks.	days
Require surgery	From enrollment to the end of treatment at 8 weeks.	yes or no