Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, 110840, China
Location status: Recruiting
Recruiting
NCT Number: NCT06410443
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury
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.
Recruiting
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Grade II-III acute radiation-induced rectosigmoid injury
- Signed informed consents
- Age ≥18 years
- Rstimated survival time >1 year
Exclusion criteria
- 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
Treatment and study plan
Dexamethasone
DrugRetention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week.
Other names: RHP
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
DrugTreatment according to guideline of radiation-induced intestinal injury.
Primary outcomes
-
Recovery and/or improvement
Time frame: 3 months
- If patients' clinical symptoms, including abdominal pain, diarrhea, and hematochezia, and intestinal mucosal lesions under endoscopy disappear, the recovery will be defined.
- 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.
Secondary outcomes
-
Recurrence and/or aggravation
Time frame: 1 year
Clinical symptoms related to radiation-induced intestinal injury and intestinal mucosal lesions under endoscopy recur or aggravate.
-
Adverse events
Time frame: 1 year
Any adverse event develop.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
General Hospital of Shenyang Military Region
Other
Registry information
Official study title
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 13, 2024
- Registry last updated
- Dec 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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