Trental & Vitamin E for Radiation-Induced Fibrosis - Full Text View

Sponsor:	University of Iowa
Information provided by:	University of Iowa
ClinicalTrials.gov Identifier:	NCT00583700

Purpose

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
Fibrosis	Drug: Pentoxifylline Drug: Vitamin E Other: control	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Vitamin E

Drug Information available for: alpha-Tocopherol DL-alpha-Tocopherol Pentoxyl Vitamin E Tocopherols Pentoxifylline Tocotrienol

U.S. FDA Resources

Further study details as provided by University of Iowa:

Primary Outcome Measures:

The primary outcome of interest is composite SOMA score at 18-month follow-up visit [ Time Frame: 18 month post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tissue compliance of the treated breast compared to the non-treated breast [ Time Frame: 12 and 18 months post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	February 2003
Estimated Study Completion Date:	December 2012
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 1 Control for study - watchful waiting.	Other: control No Pentoxifylline, no Vitamin E. Observation for 7 months, only.
Experimental: 2 Combined treatment with Pentoxifylline and Vitamin E.	Drug: Pentoxifylline Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy. Other Name: Trental Drug: Vitamin E Vitamin E (Over-the-counter) 400 I.U. once daily

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
No evidence of metastatic disease.
Minimum life expectancy of at least 12 months.
Aged greater than 20 years.
If female, pregnancy excluded.
No documented history of collagen vascular disease.

Exclusion Criteria:

Cognitively impaired patients
Prisoners
No histology available
Documented metastatic disease
Allergy to Trental
Life expectance of less than 12 months.
Aged less than 20 years
Collagen vascular disease present
Pregnant
History of liver disease
Use of anticoagulants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583700

Locations

United States, Iowa
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242

Sponsors and Collaborators

University of Iowa

Investigators

Principal Investigator:

Geraldine Jacobson, MD MPH

department of radiation oncology

More Information

Publications:

Dion MW, Hussey DH, Doornbos JF, Vigliotti AP, Wen BC, Anderson B. Preliminary results of a pilot study of pentoxifylline in the treatment of late radiation soft tissue necrosis. Int J Radiat Oncol Biol Phys. 1990 Aug;19(2):401-7.

Delanian S, Balla-Mekias S, Lefaix JL. Striking regression of chronic radiotherapy damage in a clinical trial of combined pentoxifylline and tocopherol. J Clin Oncol. 1999 Oct;17(10):3283-90.

Delanian S, Porcher R, Balla-Mekias S, Lefaix JL. Randomized, placebo-controlled trial of combined pentoxifylline and tocopherol for regression of superficial radiation-induced fibrosis. J Clin Oncol. 2003 Jul 1;21(13):2545-50.

Gothard L, Cornes P, Earl J, Hall E, MacLaren J, Mortimer P, Peacock J, Peckitt C, Woods M, Yarnold J. Double-blind placebo-controlled randomised trial of vitamin E and pentoxifylline in patients with chronic arm lymphoedema and fibrosis after surgery and radiotherapy for breast cancer. Radiother Oncol. 2004 Nov;73(2):133-9.

Delanian S, Porcher R, Rudant J, Lefaix JL. Kinetics of response to long-term treatment combining pentoxifylline and tocopherol in patients with superficial radiation-induced fibrosis. J Clin Oncol. 2005 Dec 1;23(34):8570-9. Epub 2005 Oct 31.

Responsible Party:	Geraldine Jacobson, MD, MPH, Department of radiation Oncology
ClinicalTrials.gov Identifier:	NCT00583700 History of Changes
Other Study ID Numbers:	200211003
Study First Received:	December 20, 2007
Last Updated:	July 28, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Iowa:

Breast Neoplasms
Radiotherapy

Additional relevant MeSH terms:

Fibrosis
Pathologic Processes
Pentoxifylline
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on February 09, 2012