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

Rectal Diseases Clinical Trial

Official title:

Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06325982
• Other study ID #: BYFFL-01
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Fujian Cancer Hospital
• Contact: lingdong Shao, Bachelor
• Phone: 13905914564
• Email: 1065900966[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Radiation Injuries
• Rectal Diseases
• Wounds and Injuries

Intervention

Drug:
• 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. Preparation method: Pull out the syringe piston, add 15ml triethanolamine cream, add 30ml normal saline, gently pat, shake well. Specific methods of retention enema: at night before going to bed, empty urine and feces, prepare enema liquid into the syringe, connect the special catheter, and insert the other end of the special catheter into the anus (the special catheter can be applied with lubricant such as tea oil before insertion). The patient remained prone and semi-seated. Use a special catheter, insert a special catheter about 15cm from the anus, and inject enteral liquid while withdrawing, so that the liquid is retained in the rectum; The above treatment was performed before bed and retained overnight.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence time of acute and chronic radiation rectal injury	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	Up to approximately 4 months
Primary	Evaluation of acute and chronic radiation rectal injury	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	Up to approximately 4 months
Secondary	Clinical symptom assessment	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.	Up to approximately 4 months
Secondary	Quality of life assessment assessed by IBDQ	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.	Up to approximately 4 months