Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of Radiotherapy

NCT00003825 Phase 3 COMPLETED

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.

Details

Lead sponsor	Radiation Therapy Oncology Group
Phase	Phase 3
Status	COMPLETED
Enrolment	174
Start date	1999-06

Conditions

• Diarrhea
• Radiation Enteritis

Interventions

• pentosan polysulfate sodium
• quality-of-life assessment

Countries

United States, Canada