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

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ClinicalTrials.gov Identifier: NCT00003825

Recruitment Status : Completed

First Posted : May 3, 2004

Last Update Posted : August 13, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Radiation Therapy Oncology Group

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diarrhea Radiation Enteritis	Drug: pentosan polysulfate sodium Procedure: quality-of-life assessment	Phase 3

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	174 participants
Allocation:	Randomized
Primary Purpose:	Supportive Care
Official Title:	Phase III Study of Pentosanpolysulfate (PPS) in Treatment of GI Tract Sequelae of Radiotherapy
Study Start Date :	June 1999
Actual Primary Completion Date :	April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Drug Information available for: Pentosan polysulfate Pentosan polysulfate sodium

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS: Must have received prior radiotherapy to the abdomen and pelvis and now have radiation related gastrointestinal symptoms (which were not present before the radiotherapy and/or attributed to other causes) Proctitis Diarrhea Melena (blood in stools) Severity of symptoms classified as grade 1, 2, or 3

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No bleeding ulcers No bleeding diathesis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 month since prior chemotherapy No concurrent chemotherapy Endocrine therapy: Concurrent hormonal therapy for prostate cancer allowed Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: No prior bowel resection At least 3 weeks since prior surgery Other: No concurrent anticoagulation therapy (except aspirin)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003825

Show 260 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators


Study Chair:	Miljenko V. Pilepich, MD	Saint Joseph Mercy Cancer Center

More Information

Publications of Results:

Pilepich MV, Paulus R, St Clair W, Brasacchio RA, Rostock R, Miller RC. Phase III study of pentosanpolysulfate (PPS) in treatment of gastrointestinal tract sequelae of radiotherapy. Am J Clin Oncol. 2006 Apr;29(2):132-7.


Responsible Party:	Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00003825 History of Changes
Other Study ID Numbers:	RTOG-9809 CDR0000066979 RTOG-DEV-1016
First Posted:	May 3, 2004 Key Record Dates
Last Update Posted:	August 13, 2013
Last Verified:	August 2013

Keywords provided by Radiation Therapy Oncology Group:


radiation enteritis diarrhea

Additional relevant MeSH terms:


Diarrhea Enteritis Signs and Symptoms, Digestive Signs and Symptoms Gastroenteritis	Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Pentosan Sulfuric Polyester Anticoagulants

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