Dexamethasone: Retention 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: Treatment according to guideline of radiation-induced intestinal injury.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
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.
Trial sites (1)
Facility
City
Region
Status
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang
Liaoning
Recruiting
More General Hospital of Shenyang Military Region trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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