Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy
NCT00003825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174
Last updated 2020-10-19
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.
Conditions
- Diarrhea
- Radiation Enteritis
Interventions
- DRUG
-
pentosan polysulfate sodium
- PROCEDURE
-
quality-of-life assessment
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Radiation Therapy Oncology Group
lead NETWORK
Principal Investigators
-
Miljenko V. Pilepich, MD · Saint Joseph Mercy Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
Eligibility
- Min Age
- 0 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-06-30
- Primary Completion
- 2006-04-30
Countries
- United States
- Canada
Study Locations
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