A Phase 4 interventional study of Sucralfate and Placebo in Chronic Radiation Proctitis, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Completed at 1 site in Poland. Per ClinicalTrials.gov, last updated 2012-06-07.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Phase 4, Interventional, and Treatment
The aim of this study was to compare the efficacy and safety of two treatment regimens: argon plasma coagulation (APC) alone and APC in combination with sucralfate administered for chronic hemorrhagic radiation proctopathy.
Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are difficult to treat and adversely impact patient quality of life. Various treatments directed at the reduction of blood loss and improvement of other symptoms have been evaluated, with the most encouraging results reported for two methods: endoscopic argon plasma coagulation (APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of sucralfate, a drug believed to enhance the mucosal defense and healing when administered orally or rectally. Adequately powered randomized trials comparing various treatments are lacking, and an optimal management strategy has yet to be determined. To address this issue, we conducted a single-center, randomized, placebo-controlled, double-blind study comparing the efficacy and safety of APC alone and APC in combination with sucralfate administered orally.
27 studies on the registry are indexed under Proctitis; 6 are open to participants now.
This study's enrollment of 122 is close to the median of 122 across 23 interventional studies indexed under Proctitis.
Browse Proctitis studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 64 studies on the registry; 13 are open to participants now.
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Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.
Drug: Sucralfate
Argon plasma coagulation treatment followed by placebo administration for four weeks.
Drug: Placebo
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
Also known as: Carafate, Ulgastran
Argon plasma coagulation treatment followed by placebo administration for four weeks
change in disease severity scores, as assessed using our three-item symptom scale
Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 \>6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.
Time frame: baseline vs. 16 week
change in endoscopic severity score
Endoscopic severity score of chronic radiation proctopathy: Normal, score 0 - Normal mucosa Mild, score 3 - Erythema and/or teleangiectasia, edema, thickening, pallor of mucosa Moderate, score 6 - Above plus friability Severe, score 9 - Ulceration and/or necrosis
Time frame: baseline vs. week 8 and week 16
change in disease severity score
disease severity score as in primary outcome measure
Time frame: baseline vs. week 52
complication rate
Time frame: baseline to 16 weeks
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sucralfate
Maria Sklodowska-Curie National Research Institute of Oncology