Radiation-Induced Intestinal Injury
Conditions
Keywords
Radiation-Induced Intestinal Injury, glucocorticoid
Brief summary
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as acute radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with acute radiation-induced intestinal injury. However, the conclusions of related studies were controversial.
Detailed description
A total of 60 patients with acute radiation-induced intestinal injury will be enrolled. They will be randomly assigned at a 1:1 ratio into glucocorticoid group and standard treatment group. The primary endpoint is the recovery and improvement of acute radiation-induced intestinal injury. The secondary study endpoints include the recurrence and aggravation of radiation-induced intestinal injury, and adverse events.
Interventions
DRUGDexamethasone
Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
DRUGAntibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Grade II-III acute radiation-induced rectosigmoid injury 2. Signed informed consents 3. Age ≥18 years 4. Rstimated survival time \>1 year
Exclusion criteria
1. Absolute contraindications to glucocorticoids 2. A history of glucocorticoids treatment within 3 months 3. Inflammatory bowel disease or infectious intestinal disease 4. Recurrence of malignant tumor 5. Colorectal cancer or metastasis 6. Severe heart or lung diseases 7. Recent history of surgery or trauma 8. Poorly controlled hyperglycemia and hypertension 9. Active tuberculosis 10. Ssevere gastrointestinal ulcers 11. Glaucoma 12. Sychiatric diseases 13. Pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery and/or improvement | 3 months | 1. If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined. 2. If patients' clinical symptoms alleviate, and/or the Vienna scores evaluated by endoscopy decrease at least 1 point, the improvement will be defined. The total number and frequency of patients who have both recovery and improvement of radiation-induced intestinal injury after treatment is calculated as the treatment efficacy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence and/or aggravation | 1 year | Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate. |
| Adverse events | 1 year | Any adverse event develop. |
Countries
China
Contacts
Primary ContactXingshun Qi
Backup ContactQianqian Li
Outcome results
None listed