Combined Therapy in Radiation Proctopathy

Chronic Radiation Proctitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613534
• Other study ID #: 501-2-1-09-14/03
• Status: Completed
• Phase: Phase 4
• First received: June 5, 2012
• Last updated: June 5, 2012
• Start date: June 2003
• Est. completion date: June 2007

Study information

• Verified date: June 2012
• Source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Radiation Proctitis

Intervention

Drug:
• Sucralfate
Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
• Placebo
Argon plasma coagulation treatment followed by placebo administration for four weeks

Locations

Country	Name	City	State
Poland	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	Mazowieckie

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology	Medical Centre for Postgraduate Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	change in disease severity score	disease severity score as in primary outcome measure	baseline vs. week 52	No
Secondary	complication rate		baseline to 16 weeks	Yes