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

Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled 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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xingshun Qi; Phone Number: 18909881019; Email: xingshunqi@126.com
• Study Contact Backup: Name: Qianqian Li; Phone Number: 13940307473; Email: 1208594776@qq.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110840
      • Recruiting
      • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
      • Contact: Xingshun Qi, MD; Phone Number: 86-18909881019; Email: xingshunqi@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glucocorticoids+routine treatment group; Dexamethasone retention enema	Drug: Dexamethasone; Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.; Other Names: RHP; Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation; Treatment according to guideline of radiation-induced intestinal injury.
Active Comparator: Routine treatment group; Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline	Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation; Treatment according to guideline of radiation-induced intestinal injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery and/or improvement	If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined.; 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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence and/or aggravation	Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.	1 year
Adverse events	Any adverse event develop.	1 year

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region
• Investigators: Principal Investigator: Xingshun Qi, The General Hospital of Northern Theater Command; Principal Investigator: Xiaofeng Liu, The 960th Hospital of the Chinese People's Liberation Army; Principal Investigator: Xiaohua Bao, The 964th Hospital of the Chinese People's Liberation Army; Principal Investigator: Cheng Bai, The 967th Hospital of the Chinese People's Liberation Army; Principal Investigator: Junchen Ge, The 962rd Hospital of the Chinese People's Liberation Army; Principal Investigator: Dongshuai Su, The 963rd Hospital of the Chinese People's Liberation Army; Principal Investigator: Wenda Xu, The 81th Group Military Hospital of of the Chinese People's Liberation Army; Principal Investigator: Ran Jiang, The 966th Hospital of the Chinese People's Liberation Army; Principal Investigator: Yumei Hou, 92493 Hospital of the Chinese People's Liberation Army; Principal Investigator: Hong Dai, Liaoning Provincial Corps Hospital of the Chinese People's Armed Police; Principal Investigator: Bingguo Piao, The 78th Group Military Hospital of the Chinese People's Liberation Army; Principal Investigator: Yufeng Zhang, The 79th Group Military Hospital of of the Chinese People's Liberation Army; Principal Investigator: Lichun Shao, Air Force Hospital of Northern Theater Command; Principal Investigator: Haijun Liang, 96605 Hospital of the Chinese People's Liberation Army

Publications and helpful links

General Publications

• Kochhar R, Patel F, Dhar A, Sharma SC, Ayyagari S, Aggarwal R, Goenka MK, Gupta BD, Mehta SK. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. Dig Dis Sci. 1991 Jan;36(1):103-7. doi: 10.1007/BF01300096.
• Chen W, Ma Q, Yang L, Zhang L, Zhu J, Lin W. Curative effects of montmorillonite powder combined with dexamethasone on acute radiation enteritis. Am J Transl Res. 2021 Jun 15;13(6):7270-7275. eCollection 2021.
• Li Q, Liu X, Shao L, Bao X, Bai C, Ge J, Su D, Xu W, Jiang R, Mu Z, Dai H, Piao B, Zhang Y, Liang H, Yan Y, Zhang C, Xu X, Chen J, Wang J, Zhang J, Zhang J, Zhang Y, Wang J, Yang Q, Li X, Zhang X, Hou Y, Jiang R, Jin H, Qi X, Wang H. Efficacy and safety of local glucocorticoids for the treatment of acute radiation-induced intestinal injury: protocol of a multicenter randomized controlled trial. Front Pharmacol. 2025 May 30;16:1529977. doi: 10.3389/fphar.2025.1529977. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: glucocorticoid; Radiation-Induced Intestinal Injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Micronutrients; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Nutrition Therapy; Pregnadienetriols; Feeding Methods; Nutritional Support; Nutrients; Dexamethasone; Anti-Bacterial Agents; Vitamins; Antidiarrheals; Probiotics; Enteral Nutrition
• Other Study ID Numbers: XHNKKY-RII-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No