Clinical Observation of Drug Retention Enema in Preventing Acute Radiation-induced Rectal Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFujian Cancer Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Triethanolamine cream
DrugTriethanolamine 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Triethanolamine cream groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Up to approximately 4 months2
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
Time frame
Up to approximately 4 monthsSecondary outcomes
1
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.
Time frame
Up to approximately 4 months2
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.
Time frame
Up to approximately 4 monthsSponsors and contacts
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Source ClinicalTrials.gov