Clinical trial NCT06410443: Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury
Official title: Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation-Induced Intestinal Injury
Keywords: Radiation-Induced Intestinal Injury
glucocorticoid
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery and/or improvement
timeFrame: 3 months
Secondary outcomes:
measure: Recurrence and/or aggravation
timeFrame: 1 year
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Xingshun Qi
role: PRINCIPAL_INVESTIGATOR
affiliation: The 960th Hospital of the Chinese People's Liberation Army
name: Xiaofeng Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: The 964th Hospital of the Chinese People's Liberation Army
name: Xiaohua Bao
role: PRINCIPAL_INVESTIGATOR
affiliation: The 967th Hospital of the Chinese People's Liberation Army
name: Cheng Bai
role: PRINCIPAL_INVESTIGATOR
affiliation: The 962rd Hospital of the Chinese People's Liberation Army
name: Junchen Ge
role: PRINCIPAL_INVESTIGATOR
affiliation: The 963rd Hospital of the Chinese People's Liberation Army
name: Dongshuai Su
role: PRINCIPAL_INVESTIGATOR
affiliation: The 81th Group Military Hospital of of the Chinese People's Liberation Army
name: Wenda Xu
role: PRINCIPAL_INVESTIGATOR
affiliation: The 966th Hospital of the Chinese People's Liberation Army
name: Ran Jiang
role: PRINCIPAL_INVESTIGATOR
affiliation: 92493 Hospital of the Chinese People's Liberation Army
name: Yumei Hou
role: PRINCIPAL_INVESTIGATOR
affiliation: Liaoning Provincial Corps Hospital of the Chinese People's Armed Police
name: Hong Dai
role: PRINCIPAL_INVESTIGATOR
affiliation: The 78th Group Military Hospital of the Chinese People's Liberation Army
name: Bingguo Piao
role: PRINCIPAL_INVESTIGATOR
affiliation: The 79th Group Military Hospital of of the Chinese People's Liberation Army
name: Yufeng Zhang
role: PRINCIPAL_INVESTIGATOR
affiliation: Air Force Hospital of Northern Theater Command
name: Lichun Shao
role: PRINCIPAL_INVESTIGATOR
affiliation: 96605 Hospital of the Chinese People's Liberation Army
name: Haijun Liang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.