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

Not Applicable

Recruiting

• Conditions: Radiation-Induced Intestinal Injury
• Interventions: Drug: Dexamethasone; Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation

• Registration Number: NCT06410443
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-13
• Status Verified: 2024-08
• Study Start: 2024-08-01
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-07
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucocorticoids+routine treatment group	Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation	Dexamethasone retention enema
Routine treatment group	Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation	Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline
Glucocorticoids+routine treatment group	Dexamethasone	Dexamethasone retention enema

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area); 🇨🇳 Shenyang, Liaoning, China