Combined Therapy in Radiation Proctopathy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial|
- change in disease severity scores, as assessed using our three-item symptom scale [ Time Frame: baseline vs. 16 week ] [ Designated as safety issue: No ]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.
- change in endoscopic severity score [ Time Frame: baseline vs. week 8 and week 16 ] [ Designated as safety issue: No ]
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
- change in disease severity score [ Time Frame: baseline vs. week 52 ] [ Designated as safety issue: No ]disease severity score as in primary outcome measure
- complication rate [ Time Frame: baseline to 16 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2003|
|Study Completion Date:||June 2007|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Experimental: APC plus oral sucralfate
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
Placebo Comparator: APC plus placebo
Argon plasma coagulation treatment followed by placebo administration for four weeks.
Argon plasma coagulation treatment followed by placebo administration for four weeks
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.
|Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology|
|Warsaw, Mazowieckie, Poland, 02-781|
|Principal Investigator:||Magdalena R Chruscielewska-Kiliszek, MD, PhD||Medical Centre for Postgraduate Education|