Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury.
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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