Clinical trial NCT00583700: Trental & Vitamin E for Radiation-Induced Fibrosis
Official title: Development of Radiation Fibrosis in Patients Treated With Pentoxyphylline and Vitamin E: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrosis
Keywords: Breast Neoplasms
Radiotherapy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2007-12-31
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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

Primary outcomes:
measure: Subjective, Objective, Management, and Analytic (SOMA) Score
timeFrame: 18 month post-treatment
Secondary outcomes:
measure: Tissue Compliance
timeFrame: 18 months post-treatment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: department of radiation oncology
name: Geraldine Jacobson, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/0360-3016(90)90549-y.
citation: 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. doi: 10.1200/JCO.1999.17.10.3283.
citation: 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. doi: 10.1200/JCO.2003.06.064.
citation: 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. doi: 10.1016/j.radonc.2004.09.013.
citation: 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. doi: 10.1200/JCO.2005.02.4729. Epub 2005 Oct 31.