Clinical trial NCT01613534: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Radiation Proctitis
Keywords: chronic radiation proctopathy
argon plasma coagulation
sucralfate
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Medical Centre for Postgraduate Education
First posted: 2012-06-07
Enrollment: 122
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in disease severity scores, as assessed using our three-item symptom scale
timeFrame: baseline vs. 16 week
Secondary outcomes:
measure: change in endoscopic severity score
timeFrame: baseline vs. week 8 and week 16
measure: change in disease severity score
timeFrame: baseline vs. week 52
measure: complication rate
timeFrame: baseline to 16 weeks
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Gastroenterology and Hepatology, Medical Center for Postgraduate Education and Department of Gastroenterology, Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
state: Mazowieckie
Study officials:
affiliation: Medical Centre for Postgraduate Education
name: Magdalena R Chruscielewska-Kiliszek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.