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Recruiting Phase 2

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

NCT06617182 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2024-09-30
Last updated
2026-03-27

Condition(s) studied

Radiation Enteritis

Investigational drug(s) / intervention(s)

Thalidomide →Glutamine →Thalidomide+GlutamineAll Thalidomide trials (15) →All Glutamine trials (2) →

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

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

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
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 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06617182 on ClinicalTrials.gov ↗ ← All trials in China