Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
- Conditions
- Radiation EnteritisDiarrhea
- Registration Number
- NCT00003825
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
RATIONALE: Pentosan polysulfate may be effective in treating side effects of radiation therapy to the abdomen or pelvis. It is not yet known whether pentosan polysulfate is more effective than no further therapy for treating gastrointestinal disturbance caused by previous radiation therapy.
PURPOSE: Randomized phase III trial to determine the effectiveness of pentosan polysulfate in treating patients who have inflammation of the rectum, diarrhea, or blood in stools caused by previous radiation therapy to the abdomen and pelvis.
- Detailed Description
OBJECTIVES: I. Evaluate the efficacy of pentosan polysulfate in patients with gastrointestinal tract sequelae after radiotherapy to the abdomen and pelvis. II. Determine the toxic effects of this drug in these patients. III. Determine the effect of this drug on symptoms and quality of life of these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral pentosan polysulfate three times a day for 2-6 months. Arm II: Patients receive oral placebo three times a day for 2-6 months. Both arms: Patients may receive retreatment for two months if symptoms return and last for at least 2 weeks. Quality of life is assessed before treatment, and at each follow up visit. Patients are followed every 2 months for 6 months, then every 3 months for 18 months, then annually for 3 years.
PROJECTED ACCRUAL: A total of 174 patients will be accrued for this study within 3 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 174
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (260)
University of Alabama Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Comprehensive Cancer Institute of Huntsville
🇺🇸Huntsville, Alabama, United States
Huntsville Hospital System
🇺🇸Huntsville, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Urology Associates - Mobile AL
🇺🇸Mobile, Alabama, United States
MBCCOP - University of South Alabama
🇺🇸Mobile, Alabama, United States
Alabama Oncology, LLC
🇺🇸Montgomery, Alabama, United States
Radiation Oncology Associates of West Alabama
🇺🇸Tuscaloosa, Alabama, United States
Providence Cancer Therapy Center
🇺🇸Anchorage, Alaska, United States
Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Scroll for more (250 remaining)University of Alabama Comprehensive Cancer Center🇺🇸Birmingham, Alabama, United States