Using glucocorticoids to treat intestinal injury from radiation
Efficacy and Safety of Local Glucocorticoids for the Treatment of Acute Radiation-Induced Intestinal Injury: A Randomized Controlled Trial
This study is testing if glucocorticoids can help patients who have intestinal injuries from radiation treatment feel better compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06410443 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the efficacy and safety of glucocorticoids in treating acute radiation-induced intestinal injury in patients who have undergone radiotherapy. A total of 60 patients will be randomly assigned to receive either glucocorticoid treatment or standard care. The primary focus is on the recovery and improvement of intestinal injury, while secondary endpoints include monitoring for recurrence and adverse events. The study seeks to clarify the controversial role of glucocorticoids in managing this complication.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Grade II-III acute radiation-induced rectosigmoid injury.
Not a fit: Patients with contraindications to glucocorticoids or those with certain gastrointestinal diseases will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery outcomes for patients suffering from radiation-induced intestinal injury.
How similar studies have performed: While there have been studies on glucocorticoids for various inflammatory conditions, the specific application for radiation-induced intestinal injury remains underexplored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shenyang, Liaoning
- Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Principal investigator: Xingshun Qi — The General Hospital of Northern Theater Command
- Study coordinator: Xingshun Qi
- Email: xingshunqi@126.com
- Phone: 18909881019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.