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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation Enteritis
• Intervention / Treatment: Drug: Thalidomide; Drug: Glutamine; Drug: Thalidomide+Glutamine

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yongquan Shi; Phone Number: 0086 + 02984771515; Email: shiyquan@fmmu.edu.cn

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710005
      • Recruiting
      • State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, National Clinical Research Center for Digestive Diseases, Department of Gastroenterology & Hepatology, Xijing Hospital, The Fourth Military Medical University, Xi'an, Ch
      • Contact: Yongquan Shi Prof.Shi, Dr; Phone Number: 02984771535; Email: von15991351319@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The thalidomide group; Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks.	Drug: Thalidomide; Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.
Experimental: The glutamine group; Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times 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.; Other Names: Compound glutamine enteric-coated capsules
Experimental: The thalidomide combined with glutamine group; 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.	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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yongquan Shi

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): September 27, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Enteritis; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Amino Acids; Amino Acids, Basic; Amino Acids, Diamino; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Amino Acids, Neutral; Thalidomide; Glutamine
• Other Study ID Numbers: KY20242229-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No