Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury
NCT ID: NCT06410443
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-08-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glucocorticoids+routine treatment group
Dexamethasone retention enema
Dexamethasone
Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.
Routine treatment group
Routine treatment of acute radiation-induced intestinal injury according to the current practice guideline
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.
Interventions
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Dexamethasone
Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Signed informed consents
3. Age ≥18 years
4. Rstimated survival time \>1 year
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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General Hospital of Shenyang Military Region
OTHER
Responsible Party
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Xingshun Qi
Director of Department of Gastroenterology
Principal Investigators
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Xingshun Qi
Role: PRINCIPAL_INVESTIGATOR
The General Hospital of Northern Theater Command
Xiaofeng Liu
Role: PRINCIPAL_INVESTIGATOR
The 960th Hospital of the Chinese People's Liberation Army
Xiaohua Bao
Role: PRINCIPAL_INVESTIGATOR
The 964th Hospital of the Chinese People's Liberation Army
Cheng Bai
Role: PRINCIPAL_INVESTIGATOR
The 967th Hospital of the Chinese People's Liberation Army
Junchen Ge
Role: PRINCIPAL_INVESTIGATOR
The 962rd Hospital of the Chinese People's Liberation Army
Dongshuai Su
Role: PRINCIPAL_INVESTIGATOR
The 963rd Hospital of the Chinese People's Liberation Army
Wenda Xu
Role: PRINCIPAL_INVESTIGATOR
The 81th Group Military Hospital of of the Chinese People's Liberation Army
Ran Jiang
Role: PRINCIPAL_INVESTIGATOR
The 966th Hospital of the Chinese People's Liberation Army
Yumei Hou
Role: PRINCIPAL_INVESTIGATOR
92493 Hospital of the Chinese People's Liberation Army
Hong Dai
Role: PRINCIPAL_INVESTIGATOR
Liaoning Provincial Corps Hospital of the Chinese People's Armed Police
Bingguo Piao
Role: PRINCIPAL_INVESTIGATOR
The 78th Group Military Hospital of the Chinese People's Liberation Army
Yufeng Zhang
Role: PRINCIPAL_INVESTIGATOR
The 79th Group Military Hospital of of the Chinese People's Liberation Army
Lichun Shao
Role: PRINCIPAL_INVESTIGATOR
Air Force Hospital of Northern Theater Command
Haijun Liang
Role: PRINCIPAL_INVESTIGATOR
96605 Hospital of the Chinese People's Liberation Army
Locations
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Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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Xingshun Qi, MD
Role: primary
References
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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.
Other Identifiers
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XHNKKY-RII-RCT
Identifier Type: -
Identifier Source: org_study_id