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

No results posted yet for this study

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

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003825 on ClinicalTrials.gov