Thalidomide combined with glutamine for 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

This project will test whether thalidomide plus glutamine can reduce intestinal bleeding in adults with radiation enteritis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06617182 on ClinicalTrials.gov

What this trial studies

This is a single-center, open-label, randomized phase 2 trial that assigns participants to thalidomide alone, glutamine alone, or the combination for eight weeks. Adults aged 18–80 with chronic radiation enteritis and ongoing hematochezia (≥20% of bowel movements as blood) are screened and randomized after consent. Participants keep daily stool records during treatment, have telephone follow-up every two weeks, and undergo laboratory testing every four weeks, with final assessment of stool bleeding one week after treatment ends. The trial focuses on safety and preliminary efficacy of the combination versus each agent alone in reducing bleeding and related symptoms.

Who should consider this trial

Good fit: Adults 18–80 with chronic radiation enteritis who have ongoing rectal bleeding (blood in at least 20% of bowel movements) and an ECOG score of 0–2.

Not a fit: Patients with hemodynamic instability, significant liver or kidney impairment, active tumor recurrence, or other non-radiation causes of intestinal injury are unlikely to benefit.

Why it matters

Potential benefit: If successful, the combination could reduce intestinal bleeding and improve symptoms and quality of life for patients with radiation enteritis.

How similar studies have performed: Thalidomide has been reported to help refractory gastrointestinal bleeding from vascular malformations, but using thalidomide combined with glutamine specifically for radiation enteritis is novel and not yet established.

Eligibility criteria

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.

Where this trial is running

Xi'an, Shaanxi

• 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, China (Recruiting)

Study contacts

• Study coordinator: Yongquan Shi

Conditions Radiation Enteritis