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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rectal Diseases; Radiation Injuries
• Intervention / Treatment: Drug: Triethanolamine cream

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: lingdong Shao, Bachelor; Phone Number: 0591-83660063 13905914564; Email: 1065900966@qq.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: yimin li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Triethanolamine cream group; 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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Study Chair: lingdong Shao, Bachelor, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 11, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Wounds and Injuries; Radiation Injuries; Rectal Diseases
• Other Study ID Numbers: BYFFL-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No