Overview
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.
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.
Eligibility
Inclusion Criteria:
- Grade II-III acute radiation-induced rectosigmoid injury
- Signed informed consents
- Age ≥18 years
- Rstimated survival time >1 year
Exclusion Criteria:
- Absolute contraindications to glucocorticoids
- A history of glucocorticoids treatment within 3 months
- Inflammatory bowel disease or infectious intestinal disease
- Recurrence of malignant tumor
- Colorectal cancer or metastasis
- Severe heart or lung diseases
- Recent history of surgery or trauma
- Poorly controlled hyperglycemia and hypertension
- Active tuberculosis
- Ssevere gastrointestinal ulcers
- Glaucoma
- Sychiatric diseases
- Pregnant or lactating