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Combined Therapy in Radiation Proctopathy

Primary Purpose

Chronic Radiation Proctitis

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Sucralfate
Placebo
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Radiation Proctitis focused on measuring chronic radiation proctopathy, argon plasma coagulation, sucralfate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

APC plus oral sucralfate

APC plus placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
change in disease severity score
disease severity score as in primary outcome measure
complication rate

Full Information

First Posted
June 5, 2012
Last Updated
June 5, 2012
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Medical Centre for Postgraduate Education
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1. Study Identification

Unique Protocol Identification Number
NCT01613534
Brief Title
Combined Therapy in Radiation Proctopathy
Official Title
Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Medical Centre for Postgraduate Education

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Radiation Proctitis
Keywords
chronic radiation proctopathy, argon plasma coagulation, sucralfate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APC plus oral sucralfate
Arm Type
Experimental
Arm Description
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) administration for four weeks.
Arm Title
APC plus placebo
Arm Type
Placebo Comparator
Arm Description
Argon plasma coagulation treatment followed by placebo administration for four weeks.
Intervention Type
Drug
Intervention Name(s)
Sucralfate
Other Intervention Name(s)
Carafate, Ulgastran
Intervention Description
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Argon plasma coagulation treatment followed by placebo administration for four weeks
Primary Outcome Measure Information:
Title
change in disease severity scores, as assessed using our three-item symptom scale
Description
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.
Time Frame
baseline vs. 16 week
Secondary Outcome Measure Information:
Title
change in endoscopic severity score
Description
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
Time Frame
baseline vs. week 8 and week 16
Title
change in disease severity score
Description
disease severity score as in primary outcome measure
Time Frame
baseline vs. week 52
Title
complication rate
Time Frame
baseline to 16 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena R Chruscielewska-Kiliszek, MD, PhD
Organizational Affiliation
Medical Centre for Postgraduate Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-781
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
23006660
Citation
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.
Results Reference
derived

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Combined Therapy in Radiation Proctopathy

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