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

Launched by YONGQUAN SHI · Sep 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination of two medications, thalidomide and glutamine, to see if they can help treat a condition called radiation intestinal injury, which can cause painful symptoms like bleeding in the intestines after radiation therapy for cancer. The researchers believe that thalidomide might help with this issue based on previous studies, and they want to find out if it is safe and effective when used with glutamine.

To participate in this trial, individuals must be between 18 and 80 years old and have specific symptoms related to chronic radiation intestinal injury. This includes experiencing bleeding during bowel movements at least 20% of the time in the week before starting treatment. However, not everyone can join; for example, people with serious kidney or liver problems, certain allergies, or those who are pregnant or breastfeeding will not be eligible. Participants will receive the treatment and will be monitored closely throughout the study to ensure their safety and to check how well the treatment is working. This trial is currently not open for enrollment, but it aims to help improve care for patients suffering from this challenging condition.

Gender

ALL

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.