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Efficacy and Safety of Thalidomide Combined With Glutamine in the Treatment of Radiation Intestinal Injury: a Single-center, Open-label, Randomized Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
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
RECRUITING
Xi'an
Contact Information
Primary
Yongquan Shi
shiyquan@fmmu.edu.cn
0086 + 02984771515
Time Frame
Start Date: 2024-09-30
Estimated Completion Date: 2028-11-01
Participants
Target number of participants: 150
Treatments
Experimental: The thalidomide group
Patients in the thalidomide group will receive oral thalidomide at a dosage of 100 mg one time daily for 8 weeks.
Experimental: The glutamine group
Patients in the glutamine group were given two enteric-soluble capsules of compound glutamine three times a day for 8 weeks.
Experimental: The thalidomide combined with glutamine group
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.
Sponsors
Leads: Yongquan Shi

This content was sourced from clinicaltrials.gov

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