Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury

General Hospital of Shenyang Military Region60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Radiation-Induced Intestinal Injury

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: 3 months

Secondary Outcomes

Recurrence and/or aggravation

Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.

Time frame: 1 year

Adverse events

Any adverse event develop.