Radiation Enteritis
Conditions
Brief 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.
Detailed description
Screening: This phase will not last longer than one week, and the subject will be assessed for eligibility after signing the informed consent form. Treatment: Subjects were randomly assigned to three different treatment groups for 8 weeks. Follow-up: The subjects' defecation status was recorded every day during treatment, telephone follow-up was conducted every two weeks, and laboratory indicators (including blood routine, stool routine, etc.) were tested every four weeks. The test was terminated one week after treatment and the improvement of subjects' stool blood was assessed.
Interventions
DRUGThalidomide
Patients in thalidomide group took thalidomide orally at a dose of 100mg once a day for 8 weeks.
DRUGGlutamine
In the glutamine group, two capsules of glutamine were taken orally 3 times a day for 8 weeks.
DRUGThalidomide+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.
Sponsors
Yongquan Shi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No further bleeding occurred within 1 week after treatment | From enrollment to the end of treatment at 8 weeks. | Stool occult blood negative 2 times in a row on different dates |
| Number of blood transfusions during the treatment period | From enrollment to the end of treatment at 8 weeks. | times |
| Red blood cell input | From enrollment to the end of treatment at 8 weeks. | Input red blood cells according to the situation |
| Hemoglobin level | From enrollment to the end of treatment at 8 weeks. | Record each test result |
| Number of hospitalizations due to bleeding | From enrollment to the end of treatment at 8 weeks. | times |
| Number of days in hospital due to bleeding | From enrollment to the end of treatment at 8 weeks. | days |
| Require surgery | From enrollment to the end of treatment at 8 weeks. | yes or no |
Countries
China
Contacts
CONTACTYongquan Shi
Outcome results
None listed