Trental & Vitamin E for Radiation-Induced Fibrosis

NCT00583700 | Completed Phase 2 Results DMC

• 1 other identifier: 200211003
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosis

Keywords

Breast Neoplasms; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Subjective, Objective, Management, and Analytic (SOMA) Score

  A primary outcome of interest is the composite Subjective, Objective, Management, and Analytic (SOMA) score at 18-month follow-up visit. Maximum score is 45, with a score of 0 being ideal and representing no treatment-related side effects at the study visit.

  18 month post-treatment

Secondary Outcomes (1)

• Tissue Compliance

  18 months post-treatment

Study Arms (2)

1

NO INTERVENTION

Control for study - watchful waiting.

2

EXPERIMENTAL

Combined treatment with Pentoxifylline and Vitamin E.

Drug: Pentoxifylline; Drug: Vitamin E

Interventions

Pentoxifylline DRUG

Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy.

Also known as: Trental

2

Vitamin E DRUG

Vitamin E (Over-the-counter) 400 I.U. once daily

2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

The University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• 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.

  PMID: 2394619 BACKGROUND

• 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.

  PMID: 10506631 BACKGROUND

• 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.

  PMID: 12829674 BACKGROUND

• 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.

  PMID: 15542159 BACKGROUND

• 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.

  PMID: 16260695 BACKGROUND

Related Links

• Article abstract

MeSH Terms

Conditions

Fibrosis; Breast Neoplasms

Interventions

Pentoxifylline; Vitamin E

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Small, single-institutional study. Smaller clinical trials are prone to imbalances in patient characteristics across treatment arms. t tests applied to small studies can be unduly influenced by data that contain outliers or are skewed.

Results Point of Contact

• Title: Geraldine Jacobson, MD, MBA, MPH, FACR
• Organization: West Virginia University

GMJACOBSON@hsc.wvu.edu

(304) 293-7227

Study Officials

• Geraldine Jacobson, MD MPH

  department of radiation oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 31, 2007
• Study Start: February 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2012
• Last Updated: January 29, 2013
• Results First Posted: January 29, 2013

Record last verified: 2012-10

Locations

US (1)