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

NCT06410443 | Recruiting

• 1 other identifier: XHNKKY-RII-RCT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-Induced Intestinal Injury

Keywords

Radiation-Induced Intestinal Injury; glucocorticoid

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Recurrence and/or aggravation

  1 year

• Adverse events

  1 year

Study Arms (2)

Glucocorticoids+routine treatment group

EXPERIMENTAL

Dexamethasone retention enema

Drug: Dexamethasone; Drug: Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation

Routine treatment group

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.

Also known as: RHP

Glucocorticoids+routine treatment group

Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation DRUG

Treatment according to guideline of radiation-induced intestinal injury.

Glucocorticoids+routine treatment group; Routine treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Grade II-III acute radiation-induced rectosigmoid injury
• Signed informed consents
• Age ≥18 years
• Rstimated survival time \>1 year

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, 110840, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 1670631 RESULT

• 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.

  PMID: 34306492 RESULT

• 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.

  PMID: 40520206 DERIVED

MeSH Terms

Interventions

Dexamethasone; Anti-Bacterial Agents; Probiotics; Vitamins; Antidiarrheals; Enteral Nutrition

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Micronutrients; Physiological Effects of Drugs; Nutrients; Gastrointestinal Agents; Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xingshun Qi

CONTACT

18909881019; xingshunqi@126.com

Qianqian Li

CONTACT

13940307473; 1208594776@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Gastroenterology

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 13, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)