Clinical Trials Logo
  1. Home
  2. Radiation Enteritis
  3. NCT00003825

Pentosan Polysulfate in Treating Patients With Gastrointestinal Disturbance Caused by Radiation Therapy

Diarrhea Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003825
Study type Interventional
Source Radiation Therapy Oncology Group
Contact
Status Completed
Phase Phase 3
Start date June 1999
View Details
See also
  Status Clinical Trial Phase
Completed NCT06283784 - Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients N/A
Recruiting NCT03851835 - Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis Phase 3
Completed NCT04003181 - The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon N/A
Completed NCT03596827 - The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection N/A
Recruiting NCT05372068 - Cement flooRs AnD chiLd hEalth (CRADLE) N/A
Completed NCT03972618 - Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic N/A
Completed NCT05207618 - Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant N/A
Not yet recruiting NCT05052489 - Registry and Clinical Observation of Children With Diarrhoeal Disease
Completed NCT02428647 - Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation N/A
Completed NCT02541695 - Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli N/A
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
Completed NCT01968408 - Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children Phase 3
Completed NCT01739231 - Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults Phase 1/Phase 2
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT01438645 - ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy N/A
Terminated NCT01048567 - Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly Phase 2
Not yet recruiting NCT01382199 - Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Phase 3
Terminated NCT01472211 - Water-based Zinc Intervention Trial in Zinc Deficient Children Phase 0
Completed NCT00914225 - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya N/A
Completed NCT00760851 - Yogurt Study in Children 2-4 Years Old Attending Daycare Phase 3