Combined Therapy in Radiation Proctopathy (NCT01613534) | Clinical Trial Compass
CompletedPhase 4
Combined Therapy in Radiation Proctopathy
Poland122 participantsStarted 2003-06
Plain-language 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.
Who can participate
SexALL
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Inclusion Criteria:
* radiotherapy due to pelvic tumors completed at least three months prior to enrollment
* presence of rectal bleeding
* radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy
* informed written consent to participate in the study
Exclusion Criteria:
* history of clinically significant rectal bleeding prior to radiotherapy
* conditions predisposing the patient to rectal bleeding including inflammatory bowel disease, tumors of the large bowel, intestinal vascular lesions (other than radiation-induced telangiectasia), and diversion of the fecal stream
* sucralfate treatment during the two weeks prior to enrollment
* renal insufficiency (creatinine level ≥2 mg/dl)
* concurrent chemotherapy
* concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because of drug interaction)
* concurrent therapy with oral anticoagulants
What they're measuring
1
change in disease severity scores, as assessed using our three-item symptom scale
Timeframe: baseline vs. 16 week
Trial details
NCT IDNCT01613534
SponsorMaria Sklodowska-Curie National Research Institute of Oncology