NCT00902668

Lovastatin in Reducing Side Effects After Radiation Therapy in Women With Breast Cancer

A Phase II Study Using Lovastatin to Improve Cosmetic Outcome After Radiation Therapy for Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs, such as lovastatin, may protect normal cells from the side effects of radiation therapy. PURPOSE: This phase II trial is studying how well lovastatin works in reducing side effects after radiation therapy in women with breast cancer.

Detailed description

OBJECTIVES: * To determine the incidence of good/excellent cosmetic outcome, as defined by the Harvard Scale, after radiotherapy in women treated with lovastatin, as compared to historical controls. OUTLINE: Patients undergo standard external beam whole-breast irradiation and/or accelerated partial breast irradiation. Patients receive oral lovastatin once daily beginning on the first day of radiotherapy and continuing for 12 months in the absence of disease progression or unacceptable toxicity. Patients complete a questionnaire, the Breast Cancer Treatment Outcome Scale, at baseline and then at 6 months, 12 months, and 3 years after completion of radiotherapy to assess cosmetic and functional outcomes. After completion of radiotherapy, patients are followed periodically for up to 5 years.

Conditions

• Breast Cancer
• Radiation Toxicity

Interventions

Type	Name	Description
DRUG	lovastatin
OTHER	questionnaire administration
PROCEDURE	adjuvant therapy
RADIATION	accelerated partial breast irradiation
RADIATION	external beam radiation therapy

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-04-01
• Completion: 2013-04-01
• First posted: 2009-05-15
• Last updated: 2013-06-20
• Results posted: 2013-05-30