Thalidomide combined with glutamine for radiation intestinal injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: shiyquan@fmmu.edu.cn
• Phone: 0086 + 02984771515

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How types of radiation-caused rectal injury relate to recovery and outcomes

  This project will try to see if different clinical types of radiation-caused rectal injury predict recovery and long-term outcomes in adults aged 18–80.

  Recruiting Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong · NCT07378631

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.