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

NCT06617182 | Recruiting Phase 2

• 1 other identifier: KY20242229-F-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Enteritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• No further bleeding occurred within 1 week after treatment

  From enrollment to the end of treatment at 8 weeks.

• Number of blood transfusions during the treatment period

  From enrollment to the end of treatment at 8 weeks.

• Red blood cell input

  From enrollment to the end of treatment at 8 weeks.

• Hemoglobin level

  From enrollment to the end of treatment at 8 weeks.

• Number of hospitalizations due to bleeding

  From enrollment to the end of treatment at 8 weeks.

Study Arms (3)

The thalidomide group

EXPERIMENTAL

Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks.

Drug: Thalidomide

The glutamine group

EXPERIMENTAL

Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks.

Drug: Glutamine

The thalidomide combined with glutamine group

EXPERIMENTAL

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

Interventions

Thalidomide DRUG

Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.

The thalidomide group

Glutamine DRUG

In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks.

Also known as: Compound glutamine enteric-coated capsules

The glutamine group

Thalidomide+Glutamine DRUG

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.

The thalidomide combined with glutamine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yongquan Shi: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710005, China

RECRUITING

MeSH Terms

Interventions

Thalidomide; Glutamine

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Central Study Contacts

Yongquan Shi

CONTACT

0086 + 02984771515; shiyquan@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)