An interventional study of Triethanolamine cream in Radiation Injuries and Rectal Diseases, sponsored by Fujian Cancer Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Fujian Cancer Hospital · Not applicable, Interventional, and Prevention
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.
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.
328 studies on the registry are indexed under Radiation Injuries; 96 are open to participants now.
This study's planned enrollment of 200 is above the median of 72 across 216 interventional studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →Fujian Cancer Hospital is the lead sponsor of 163 studies on the registry; 93 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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 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
Time frame: Up to approximately 4 months
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 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.
Time frame: Up to approximately 4 months
Plan to share: No
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