Combined Therapy in Radiation Proctopathy

NCT ID: NCT01613534

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2007-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

APC plus oral sucralfate

Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.

Group Type: EXPERIMENTAL

Sucralfate

Intervention Type: DRUG

Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks

APC plus placebo

Argon plasma coagulation treatment followed by placebo administration for four weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Argon plasma coagulation treatment followed by placebo administration for four weeks

Interventions

Sucralfate

Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks

Intervention Type: DRUG

Placebo

Argon plasma coagulation treatment followed by placebo administration for four weeks

Intervention Type: DRUG

Other Intervention Names

Carafate; Ulgastran

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Centre for Postgraduate Education

UNKNOWN

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magdalena R Chruscielewska-Kiliszek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Centre for Postgraduate Education

Locations

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, Masovian Voivodeship, Poland

Countries

Poland

References

Chruscielewska-Kiliszek MR, Regula J, Polkowski M, Rupinski M, Kraszewska E, Pachlewski J, Czaczkowska-Kurek E, Butruk E. Sucralfate or placebo following argon plasma coagulation for chronic radiation proctitis: a randomized double blind trial. Colorectal Dis. 2013 Jan;15(1):e48-55. doi: 10.1111/codi.12035.

Reference Type: DERIVED

PMID: 23006660 (View on PubMed)

Other Identifiers

501-2-1-09-14/03

Identifier Type: -

Identifier Source: org_study_id