Combined Therapy in Radiation Proctopathy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Radiation Proctitis

Intervention / Treatment
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* Drug: Sucralfate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic radiation proctopathy, argon plasma coagulation, sucralfate