Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury

Not Applicable

Recruiting

• Conditions: Rectal Diseases; Radiation Injuries
• Interventions: Drug: Triethanolamine cream

• Registration Number: NCT06325982
• Lead Sponsor: Fujian Cancer Hospital

Brief Summary

The main objective of this study was to evaluate the efficacy and safety of drug retention enema for the prevention of acute radiation rectal injury in the real world.

Detailed Description

The study was a prospective, multicenter, real-world study with eligible patient data as of May 1, 2024. The prospective study was a continuous, multicenter study.

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-22
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Study Start: 2024-06-11
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triethanolamine cream group	Triethanolamine cream	Triethanolamine cream retention enema was given once every night before going to bed during radiotherapy until the end of radiotherapy. Triethanolamine cream retention enema was given once before going to bed the day after radiotherapy for 3 months

Primary Outcome Measures

Name	Time	Method
Occurrence time of acute and chronic radiation rectal injury	Up to approximately 4 months	RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The time (days) of acute radiation rectal injury were evaluated and recorded
Evaluation of acute and chronic radiation rectal injury	Up to approximately 4 months	RTOG/EORTC criteria were used to evaluate the severity of acute and chronic radiation rectal injury. The grading of acute radiation rectal injury were evaluated and recorded

Secondary Outcome Measures

Name	Time	Method
Clinical symptom assessment	Up to approximately 4 months	Clinical symptoms were assessed using the Simple Clinical Colitis Activity Index (SCCAI) designed by the Inflammatory Bowel Disease Research Group at the Royal Free Hospital School of Medicine.; SCCAI in this study included 6 items, with a total score of 0-16. The higher the score, the more severe the symptoms.
Quality of life assessment assessed by IBDQ	Up to approximately 4 months	The quality of life index (IBDQ) was used to evaluate the quality of life of patients with inflammatory bowel disease.; IBDQ included 32 questions in 4 aspects: intestinal symptoms (10), systemic symptoms (5), emotional ability (12) and social ability (5). Each question was divided into 7 grades, with a total score of 32-224 points. The higher the score, the better the quality of life. Scores above 177 indicate light, 176-121 indicate medium, and below 120 indicate heavy.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China