Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

PRIMARY OBJECTIVES:

I. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease
of dehydration, and reduction in the appearance of inflammation associated with radiation
therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the
application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer
patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end
of radiation therapy (approximately 3-6 weeks).

GROUP II: Patients receive standard of care as directed by radiation oncologist until the end
of radiation therapy (approximately 3-6 weeks).

After completion of study treatment, patients are followed up at 4-6 weeks.

Inclusion Criteria:

- Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6
weeks of radiation therapy (radiation protocol of 42 Gy+)

- Area to be irradiated representing 1-10% of total body surface area (TBSA)

- Able and willing to sign protocol consent form

- Able and willing to document symptoms and treatment details as often as needed, not to
exceed daily notes

- Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

- Women who are pregnant, lactating/nursing or plan to become pregnant

- Previous radiation therapy to the area to be treated with radiation therapy

- Receiving palliative radiation therapy

- Unhealed or infected surgical sites in the irradiation area

- Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall
treatment plan (tamoxifen/aromatase inhibitor allowed)

- Use of oral corticosteroids or topical corticosteroids in the irradiation area

- Use of Erbitux

- Autoimmune disease

- Skin disease in target irradiation area

- Smoker

- Known allergy to the standard of care or ingredients in KeraStat Cream