DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Combined Therapy in Radiation Proctopathy

Information source: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Radiation Proctitis

Intervention: Sucralfate (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology

Official(s) and/or principal investigator(s):
Magdalena R Chruscielewska-Kiliszek, MD, PhD, Principal Investigator, Affiliation: Medical Centre for Postgraduate Education

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.

Clinical Details

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

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

Primary outcome: change in disease severity scores, as assessed using our three-item symptom scale

Secondary outcome:

change in endoscopic severity score

change in disease severity score

complication rate

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

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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 02-781, Poland
Additional Information

Starting date: June 2003
Last updated: June 5, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017