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Sponsored by: |
University of Iowa |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00583700 |
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
Condition | Intervention | Phase |
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Fibrosis |
Drug: Pentoxifylline Drug: Vitamin E Other: control |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study |
Estimated Enrollment: | 56 |
Study Start Date: | February 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: No Intervention
Control for study - watchful waiting.
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Other: control
No Pentoxifylline, no Vitamin E. Observation for 7 months, only.
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2: Experimental
Combined treatment with Pentoxifylline and Vitamin E.
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Drug: Pentoxifylline
Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.
Drug: Vitamin E
Vitamin E (Over-the-counter) 400 I.U. once daily
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Radiation fibrosis occurs in approximately 25% of those women treated with radiation for breast cancer. Of these, approximately 3 to 5% will develop into an acute, painful form of fibrosis. Mild fibrosis can present as a thicker or more dense breast where the acute form can cause pain in the breast, significant hardening, and inflammation.
Treatments for fibrosis are lacking, with the primary treatment being hyperbaric oxygen therapy. The combination of Trental & Vitamin E has been used with success in Europe and at the University of Iowa.
The focus of this study is to prevent fibrosis through intervention with Trental & Vitamin E. The study has two arms, a control arm and an intervention arm. The study is not blinded. Measurements are taken at standard follow-up visits to measure breast density and lymphedema.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kellie Bodeker, B.Sc., CCRC | (319) 384-9425 | kellie-bodeker@uiowa.edu |
Contact: Jane Hershberger, R.N. | (319) 353-8973 | jane-hershberger@uiowa.edu |
United States, Iowa | |
The University of Iowa Hospitals & Clinics | Recruiting |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Geraldine Jacobson, MD MPH | department of radiation oncology |
Responsible Party: | Department of radiation Oncology ( Geraldine Jacobson, MD, MPH ) |
Study ID Numbers: | 200211003 |
Study First Received: | December 20, 2007 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00583700 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Neoplasms Radiotherapy |
Tocopherol acetate Radiation-Protective Agents Vasodilator Agents Antioxidants Fibrosis Breast Neoplasms Trace Elements Cardiovascular Agents Pentoxifylline |
Alpha-Tocopherol Tocopherols Vitamin E Phosphodiesterase Inhibitors Vitamins Tocotrienols Platelet Aggregation Inhibitors Micronutrients |
Radiation-Protective Agents Vasodilator Agents Antioxidants Molecular Mechanisms of Pharmacological Action Fibrosis Hematologic Agents Physiological Effects of Drugs Pentoxifylline Tocopherols Pathologic Processes Vitamins Therapeutic Uses Free Radical Scavengers |
Tocotrienols Micronutrients Tocopherol acetate Growth Substances Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Alpha-Tocopherol Vitamin E Phosphodiesterase Inhibitors Platelet Aggregation Inhibitors |