Combined Therapy in Radiation Proctopathy

Maria Sklodowska-Curie National Research Institute of Oncology122 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

122

Conditions

Chronic Radiation Proctitis

Interventions

SucralfateDRUG

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

PlaceboDRUG

Argon plasma coagulation treatment followed by placebo administration for four weeks

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

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

Outcomes

Primary Outcomes

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.

Time frame: baseline vs. 16 week

Secondary Outcomes

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

Time frame: baseline vs. week 8 and week 16

change in disease severity score

disease severity score as in primary outcome measure

Time frame: baseline vs. week 52

complication rate

Time frame: baseline to 16 weeks

Data from ClinicalTrials.gov

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