HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer

Randomized, Double-Blind, Vehicle-Controlled Pilot Study of the Efficacy and Safety of HylaCareTM in the Treatment of Acute Skin Changes in Patients Undergoing External Beam Radiotherapy for Tumors of the Breast.

This will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of HylaCareTM. The study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. Each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. The product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. The study drug and placebo will be applied three (3) times daily.

Patients will be allocated to the treatment using a randomized permuted block. There will be no stratification. Patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. Patients and clinical investigators will be blinded to the treatment assignments.

Inclusion Criteria:

• Female, age 18 or older
• Diagnosis of breast cancer
• Intact breast (not surgically absent)
• Planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 Gy in 28 fractions with a planned photon or electron boost of 10Gy in 5 fractions (for a total of 33 fractions)
• Ability to understand and comply with the requirements of this study
• Ability to give Informed Consent
• For sexually active females, patient agrees to use acceptable method of birth control

Exclusion Criteria:

• Women who are pregnant or lactating
• Use of concomitant skin care preparations at any of the treated or control portal areas to be observed
• Any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis
• Severe renal failure creatinine > 3.0 within 6 months of study registration
• Allergic history, including anaphylaxis or severe allergies to products in study serum or placebo
• Planned relocation which would make follow-up visits impossible during the course of the study
• Collagen vascular disease such as Lupus, or scleroderma