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

Phase 3
Completed
Conditions
Radiation Enteritis
Diarrhea
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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

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