Using a drug enema to prevent radiation-induced rectal injury
Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study
This study tests if a special drug enema can help prevent rectal injuries in patients receiving radiation therapy for pelvic or rectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Fujian Cancer Hospital Government |
| Drugs / interventions | radiation |
| Locations | 1 site (Xiamen, Fujian) |
| Trial ID | NCT06325982 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of a drug retention enema in preventing acute rectal injuries caused by radiation therapy. It is a prospective, multicenter study that collects data from eligible patients receiving pelvic or rectal radiotherapy. The study aims to gather real-world evidence on the intervention's impact on patient outcomes. Participants will be monitored for their compliance and cooperation throughout the study.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for pelvic or rectal radiotherapy with an ECOG score of 0-1 and high compliance.
Not a fit: Patients with pre-existing intestinal diseases or serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute radiation-induced rectal injuries in patients undergoing radiotherapy.
How similar studies have performed: While similar approaches have been explored, this specific intervention in a real-world setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * There are clear indications for radiotherapy (pelvic radiotherapy or rectal radiotherapy) according to relevant guidelines; * ECOG score 0-1; * normal mind, clear consciousness; * High compliance; * Able to cooperate with the interviewer Exclusion Criteria: * Poor compliance, unwilling to participate or unable to cooperate with the interviewer; * Patients with other intestinal diseases (such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, etc.) and perianal diseases; * serious heart, brain, liver, kidney disease; * Long-term immune dysfunction; * Pregnant or lactating women; * Patients who terminate treatment for various reasons.
Where this trial is running
Xiamen, Fujian
- The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (Recruiting)
Study contacts
- Study coordinator: lingdong Shao, Bachelor
- Email: 1065900966@qq.com
- Phone: 13905914564
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.