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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glucocorticoids+routine treatment group | Experimental | Dexamethasone retention enema |
|
| Routine treatment group | Active Comparator | Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recovery and/or improvement |
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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingshun Qi | Contact | 18909881019 | xingshunqi@126.com | |
| Qianqian Li | Contact | 13940307473 | 1208594776@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) | Recruiting | Shenyang | Liaoning | 110840 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1670631 | Result | 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. | |
| 34306492 | Result |
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| Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation | Drug | Treatment according to guideline of radiation-induced intestinal injury. |
|
| 1 year |
| 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 |
|
| 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. |
| 40520206 | Derived | 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. |
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000900 | Anti-Bacterial Agents |
| D019936 | Probiotics |
| D014815 | Vitamins |
| D000930 | Antidiarrheals |
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D018977 | Micronutrients |
| D045505 | Physiological Effects of Drugs |
| D000078622 | Nutrients |
| D005765 | Gastrointestinal Agents |
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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