Combined Therapy in Radiation Proctopathy

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Radiation Proctitis
• Intervention / Treatment: Drug: Sucralfate; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 02-781
      • Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APC plus oral sucralfate; Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.	Drug: Sucralfate; Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks; Other Names: Carafate; Ulgastran
Placebo Comparator: APC plus placebo; Argon plasma coagulation treatment followed by placebo administration for four weeks.	Drug: Placebo; Argon plasma coagulation treatment followed by placebo administration for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in disease severity scores, as assessed using our three-item symptom scale	Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 >6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.	baseline vs. 16 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in endoscopic severity score	Endoscopic severity score of chronic radiation proctopathy: Normal, score 0 - Normal mucosa Mild, score 3 - Erythema and/or teleangiectasia, edema, thickening, pallor of mucosa Moderate, score 6 - Above plus friability Severe, score 9 - Ulceration and/or necrosis	baseline vs. week 8 and week 16
change in disease severity score	disease severity score as in primary outcome measure	baseline vs. week 52
complication rate		baseline to 16 weeks

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Medical Centre for Postgraduate Education
• Investigators: Principal Investigator: Magdalena R Chruscielewska-Kiliszek, MD, PhD, Medical Centre for Postgraduate Education

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2003
• Primary Completion (Actual): June 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: June 5, 2012
• First Submitted That Met QC Criteria: June 5, 2012
• First Posted (Estimate): June 7, 2012

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 5, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: argon plasma coagulation; chronic radiation proctopathy; sucralfate
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Rectal Diseases; Proctitis; Gastrointestinal Agents; Anti-Ulcer Agents; Sucralfate
• Other Study ID Numbers: 501-2-1-09-14/03