About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Grade II-III acute radiation-induced rectosigmoid injury
Signed informed consents
Age ≥18 years
Rstimated survival time >1 year
Disqualifiers
Absolute contraindications to glucocorticoids
A history of glucocorticoids treatment within 3 months
Inflammatory bowel disease or infectious intestinal disease
Recurrence of malignant tumor
Trial design
Parallel
Treatments tested in this trial
Dexamethasone
DrugRetention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
DrugTreatment according to guideline of radiation-induced intestinal injury.
Treatment groups
Trial outcomes
Primary outcomes
Recovery and/or improvement
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 outcomes
Recurrence and/or aggravation
Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.
Adverse events
Any adverse event develop.
Sponsors and contacts
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