Combined Therapy in Radiation Proctopathy
Information source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Radiation Proctitis
Intervention: Sucralfate (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology Official(s) and/or principal investigator(s): Magdalena R Chruscielewska-Kiliszek, MD, PhD, Principal Investigator, Affiliation: Medical Centre for Postgraduate Education
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.
Clinical Details
Official title: Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: change in disease severity scores, as assessed using our three-item symptom scale
Secondary outcome: change in endoscopic severity scorechange in disease severity score complication rate
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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 02-781, Poland
Additional Information
Starting date: June 2003
Last updated: June 5, 2012
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