Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Efficacy and Safety of Local Glucocorticoids for the Treatment of Radiation-Induced Intestinal Injury: A Randomized Controlled Trial

ID
Name
XHNKKY-RII-RCT
Description
Due to the increasing number and prolonged survival of malignant tumor patients treated with radiotherapy, the complication, such as radiation-induced intestinal injury, has become increasingly significant. Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with radiation-induced intestinal injury. However, the conclusions of related studies were controversial.
Trial arms
Trial start
2024-07-01
Estimated PCD
2026-12-31
Trial end
2026-12-31
Status
Not yet recruiting
Treatment
Dexamethasone
Glucocorticoids may play a therapeutic role by regulating the inflammatory response in patients with radiation-induced intestinal injury.
Arms:
Glucocorticoids group
Other names:
Glucocorticoids
Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury
Arms:
Standard treatment group
Size
60
Primary endpoint
Recovery and/or improvement
3 months
Eligibility criteria
Inclusion Criteria: 1. Grade I-II 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. Requirement of surgical treatment for radiation-induced intestinal injury 3. Recurrence of malignant tumor or rectal metastasis 4. Recent history of surgery or trauma 5. Severe heart or lung diseases 6. Psychiatric diseases 7. Pregnant or lactating
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-05-13

1 organization

2 products

1 indication

Organization
General Hospital of Shenyang Military Region
Product
Dexamethasone
Indication
Radiation-Induced Intestinal Injury
Product
Antibiotics