NCT01613534

Combined Therapy in Radiation Proctopathy

Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Radiation Proctitis

Interventions

Type	Name	Description
DRUG	Sucralfate	Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
DRUG	Placebo	Argon plasma coagulation treatment followed by placebo administration for four weeks

Timeline

• Start date: 2003-06-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2012-06-07
• Last updated: 2012-06-07

Locations

1 site across 1 country: Poland