Combined Therapy in Radiation Proctopathy

Maria Sklodowska-Curie National Research Institute of Oncology

Status and phase: Completed; Phase 4

Conditions: Chronic Radiation Proctitis

Treatments: Drug: Placebo; Drug: Sucralfate

Study type: Interventional

Funder types: Other

Identifiers

NCT01613534

501-2-1-09-14/03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

APC plus oral sucralfate

Experimental group

Description:

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

Treatment:

Drug: Sucralfate

APC plus placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo