Trial Information

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.

Safety report will be sent to the local independent ethics committee after the examination
of the first ten patients.

The protective effect of the cream containing calcipotriol will be compared to the standard
treatment and analyzed statistically using the parameters mention above. The relation
between the background disease, medications, allergies, weight, habits, size of the
irradiated breast, sun exposure, previous chemotherapy treatment and exposure to sunlight
and the skin reaction will be evaluated.

INCLUSION CRITERIA

1. . Age ranging from 18 to 75.

2. . Confirmed histological diagnosis of Breast cancer.

3. . Radiotherapy treatment to the breast following lumpectomy.

EXCLUSION CRITERIA

1. . Scleroderma.

2. . An extremely large breast. Interfiled above 25 cm.

3. . Prior radiotherapy to the same breast, radiotherapy to the contra lateral breast is
not a contraindication.

4. . Mastectomy.