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

NCT06325982 | Recruiting

• 1 other identifier: BYFFL-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Injuries; Rectal Diseases

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Clinical symptom assessment

  Up to approximately 4 months

• Quality of life assessment assessed by IBDQ

  Up to approximately 4 months

Study Arms (1)

Triethanolamine cream group

EXPERIMENTAL

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

Interventions

Triethanolamine cream DRUG

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.

Triethanolamine cream group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

MeSH Terms

Conditions

Radiation Injuries; Rectal Diseases

Condition Hierarchy (Ancestors)

Wounds and Injuries; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• lingdong Shao, Bachelor

  Fujian Cancer Hospital

  STUDY CHAIR

Central Study Contacts

lingdong Shao, Bachelor

CONTACT

13905914564; 1065900966@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 22, 2024
• Study Start: June 11, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)