STUDY PROTOCOL article

Front. Pharmacol.

Sec. Gastrointestinal and Hepatic Pharmacology

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1529977

This article is part of the Research TopicWomen in Gastrointestinal and Hepatic Pharmacology: 2024View all articles

Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: Protocol of a Multicenter Randomized Controlled

Provisionally accepted
Qianqian LiQianqian Li1Xiaofeng LiuXiaofeng Liu2Lichun ShaoLichun Shao3Xiaohua BaoXiaohua Bao4Cheng BaiCheng Bai5Junchen GeJunchen Ge6Dongshuai SuDongshuai Su7Wenda XuWenda Xu8Ran JiangRan Jiang9Zhenbin MuZhenbin Mu10Hong DaiHong Dai11Bingguo PiaoBingguo Piao12Yufeng ZhangYufeng Zhang13Haijun LiangHaijun Liang14Ying YanYing Yan15Cheng ZhangCheng Zhang16Xiangbo XuXiangbo Xu1Jiang ChenJiang Chen1Jing WangJing Wang2Jian ZhangJian Zhang17Jie ZhangJie Zhang4Yibo ZhangYibo Zhang5Jing WangJing Wang6Qingyu YangQingyu Yang7Xiaoqin LiXiaoqin Li8Xiaoyu ZhangXiaoyu Zhang9Yumei HouYumei Hou10Ruosi JiangRuosi Jiang11Huafeng JinHuafeng Jin12Xingshun QiXingshun Qi1*Huishan WangHuishan Wang18*
  • 1Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China
  • 2Department of Gastroenterology, The 960th Hospital of the Chinese people’s Liberation Army, Jinan, China
  • 3Department of Gastroenterology, Air Force Hospital of Northern Theater Command, Shenyang, China
  • 4Department of Gastroenterology, The 964th Hospital of the Chinese People’s Liberation Army, Changchun, China
  • 5Department of Gastroenterology, The 967th Hospital of Chinese People’s Liberation Army, Dalian, Liaoning Province, China
  • 6Department of Gastroenterology, The 962rd Hospital of the Chinese People’s Liberation Army, Harbin, China
  • 7Respiratory and Digestive Department, The 963rd Hospital of the Chinese People’s Liberation Army, Jiamusi, China
  • 8Department of Gastroenterology, The 81th Group Military Hospital of of the Chinese People’s Liberation Army, Zhangjiakou, China
  • 9Department of Gastroenterology, The 966th Hospital of the Chinese People’s Liberation Army, Dandong, China
  • 10Department of Gastroenterology, The 92493 Hospital of the Chinese People’s Liberation Army, Huludao, China
  • 11Department of Internal Medicine, Liaoning Provincial Corps Hospital of the Chinese People's Armed Police Force, Shenyang, Liaoning Province, China
  • 12Department of Gastroenterology, The 78th Group Military Hospital of the Chinese People’s Liberation Army, Mudanjiang, China
  • 13Department of Gastroenterology, The 79th Group Military Hospital of of the Chinese People’s Liberation Army, Liaoyang, China
  • 14Endoscopy Center, The 96605 Hospital of the Chinese People’s Liberation Army, Tonghua, China
  • 15Department of Radiation Oncology, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China
  • 16Department of General Surgery, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China
  • 17Department of Gastroenterology, Air Force Hospital of Northern Theater Command, Shenyang, Liaoning Province, China
  • 18Department of Cardiovascular Surgery, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China

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Background and aims: Acute radiation-induced intestinal injury (ARII) usually occurs after pelvic radiotherapy. Glucocorticoids are potentially effective for the treatment of ARII due to their anti-inflammatory properties, but the currently available evidence is insufficient. Herein, we have designed a multicenter randomized controlled trial (RCT) to explore the efficacy and safety of glucocorticoids for the treatment of ARII. Methods: Overall, 60 patients with ARII will be enrolled. Eligible patients will be stratified according to the grade of ARII and randomly assigned at a ratio of 1:1 to the routine treatment alone and in combination with local glucocorticoids groups. The primary endpoints include the recovery and improvement of ARII. The secondary endpoints include the recurrence and aggravation of ARII and adverse events of glucocorticoids. Discussion: This RCT will provide high-quality evidence to clarify the role of local glucocorticoids for the treatment of ARII.Trial registration: ClinicalTrials.gov Identifier: NCT06410443.

Keywords: Glucocorticoids, Enema, Intestinal injury, Radiotherapy, randomized controlled trial

Received: 18 Nov 2024; Accepted: 22 May 2025.

Copyright: © 2025 Li, Liu, Shao, Bao, Bai, Ge, Su, Xu, Jiang, Mu, Dai, Piao, Zhang, Liang, Yan, Zhang, Xu, Chen, Wang, Zhang, Zhang, Zhang, Wang, Yang, Li, Zhang, Hou, Jiang, Jin, Qi and Wang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

* Correspondence:
Xingshun Qi, Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China
Huishan Wang, Department of Cardiovascular Surgery, General Hospital of Northern Theater Command, Shenyang, Liaoning Province, China

Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

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