Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast.

STUDY PROTOCOL

Fifty women diagnosed with breast cancer planned to receive adjuvant radiotherapy, will participate in the study. About 15 minutes after receiving the daily radiation dose fraction, a cream containing an active vitamin D analogue will be applied to half of the breast with inspection of a nurse. The other half of the breast will have a standard cream applied . During the days that radiotherapy is not administered the standard cream will be applied to both halves of the breast in a case of strong reaction to radiotherapy (e.g. strong erythema, painful tenderness etc.)The adverse skin effects will be assessed according to the following criteria:

1. . an assessment by a physician and a nurse according to the RTOG score (6).

As follows:

Grade 0 - no reaction. Grade 1 - light erythema dry peeling, decrease in sweat production. Grade 3 - extensive moist peeling, pitting edema. Grade 4 - ulcers, bleeding and necrosis. 2. . A questionnaire to each patient regarding the efficacy and safety of the cream. 3. . Number of interruption of radiotherapy treatment. The assessment will be done each week during radiotherapy treatment and weekly for three weeks following the completion of radiotherapy treatment.