Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexamethasone, Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation.
- Who it may be relevant to
- Registry conditions: Radiation-Induced Intestinal Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Dexamethasone
Retention enema with 10mg dexamethasone, once a day, the total course of treatment for 1 week. - Drug Antibiotics, probiotics, vitamins, antidiarrheal drugs, enteral nutrition, and endoscopic argon plasma coagulation
Treatment according to guideline of radiation-induced intestinal injury.
Primary outcome measures
- Recovery and/or improvement [Time frame: 3 months]
Secondary outcome measures (2)
- Recurrence and/or aggravation [Time frame: 1 year]
- Adverse events [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly cal — Shenyang
Publications
- 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. PMID 1670631
- 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. PMID 34306492
- 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. Fr PMID 40520206
Identifiers
NCT: NCT06410443 · XHNKKY-RII-RCT