Combined Therapy in Radiation Proctopathy

• ClinicalTrials.gov Identifier: NCT01613534
• Recruitment Status: Completed
• First Posted: June 7, 2012
• Last Update Posted: June 7, 2012
• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborator: Medical Centre for Postgraduate Education
• Information provided by (Responsible Party): Maria Sklodowska-Curie National Research Institute of Oncology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Radiation Proctitis	Drug: Sucralfate; Drug: Placebo	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
• Study Start Date: June 2003
• Actual Primary Completion Date: June 2007
• Actual Study Completion Date: June 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. change in disease severity scores, as assessed using our three-item symptom scale [ Time Frame: baseline vs. 16 week ]
   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.

Secondary Outcome Measures :

1. change in endoscopic severity score [ Time Frame: baseline vs. week 8 and week 16 ]

   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

2. change in disease severity score [ Time Frame: baseline vs. week 52 ]
   disease severity score as in primary outcome measure
3. complication rate [ Time Frame: baseline to 16 weeks ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Poland

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, Poland, 02-781

Sponsors and Collaborators

Maria Sklodowska-Curie National Research Institute of Oncology

Medical Centre for Postgraduate Education

Investigators

• Principal Investigator: Magdalena R Chruscielewska-Kiliszek, MD, PhD; Medical Centre for Postgraduate Education

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Maria Sklodowska-Curie National Research Institute of Oncology
• ClinicalTrials.gov Identifier: NCT01613534
• Other Study ID Numbers: 501-2-1-09-14/03
• First Posted: June 7, 2012
• Last Update Posted: June 7, 2012
• Last Verified: June 2012

Keywords provided by Maria Sklodowska-Curie National Research Institute of Oncology:

chronic radiation proctopathy; argon plasma coagulation; sucralfate

Additional relevant MeSH terms:

Proctitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Intestinal Diseases; Sucralfate; Anti-Ulcer Agents; Gastrointestinal Agents