Actively Recruiting
Clinical Observation of Trolamine Retention Enema in Preventing Acute Radiation-induced Rectal Injury: a Real-world Multicenter Prospective Study
Led by Fujian Cancer Hospital · Updated on 2024-06-05
200
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of a drug retention enema containing triethanolamine cream to prevent acute radiation rectal injury in patients undergoing pelvic or rectal radiotherapy. This real-world, prospective, multicenter study aims to assess both the safety and effectiveness of this treatment in preventing radiation-induced rectal damage. Participants receive a triethanolamine cream retention enema once every night before bed during the course of radiotherapy. After completing radiotherapy, the enema is continued once nightly for an additional three months. The enema is prepared by mixing 15ml of triethanolamine cream with 30ml of normal saline and administered via a special catheter inserted about 15cm into the rectum, with the liquid retained overnight. During the study, researchers will monitor the timing and occurrence of acute and chronic radiation rectal injuries for up to approximately four months. Clinical symptoms will be assessed alongside quality of life measurements using the Inflammatory Bowel Disease Questionnaire (IBDQ). Participants' compliance and cooperation will be closely observed throughout the study period. The study is led by Fujian Cancer Hospital and began in June 2024.
CONDITIONS
Brief Title
Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clear indication for pelvic or rectal radiotherapy according to relevant guidelines
- ECOG performance status score of 0-1
- Normal mental status and clear consciousness
- High compliance with study requirements
- Able to cooperate with study interviews and procedures
You will not qualify if you...
- Poor compliance or unwillingness to participate or cooperate with study procedures
- Presence of other intestinal diseases such as Crohn's disease, rectal ulcer, anal fissure, anal fistula, hemorrhoids, or perianal diseases
- Serious heart, brain, liver, or kidney diseases
- Long-term immune system dysfunction
- Pregnant or lactating women
- Patients who discontinue treatment for any reason
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiotherapy plus 3 months after radiotherapy
Participants receive a triethanolamine cream retention enema once every night before going to bed during radiotherapy, continuing until the end of radiotherapy. After radiotherapy ends, participants continue to receive the enema once before going to bed daily for 3 months.
Daily treatment overnight
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Actively Recruiting
Research Team
L
lingdong Shao, Bachelor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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