Combined Therapy in Radiation Proctopathy

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maria Sklodowska-Curie Institute - Oncology Center; Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Collaborator: Medical Centre for Postgraduate Education
• Treatments: Sucralfate

Criteria

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