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Sponsored by: |
Rabin Medical Center |
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Information provided by: | Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT00445250 |
Examining the hypothesis that protecting keratinocytes by calcipotriol can prevent in-vivo cutaneous side effect in patients receiving radiotherapy to the breast. To check the connection between the skin effect of radiotherapy and different parameters including diseases such as diabetes and lupus, use of medications, allergies, weight, habits, size of the irradiated breast, previous chemotherapy treatment and exposure to sunlight.
Condition | Intervention | Phase |
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Radiodermatitis |
Drug: Calcipotriol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast. |
Estimated Enrollment: | 50 |
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:
. 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.
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
EXCLUSION CRITERIA
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eyal Fenig, M.D. | 97239377964 | efenig@clalit.org.il |
Contact: Ofer Purim, M.D. | 97239377973 | oferp@clalit.org.il |
Israel | |
Rabin Medical Center | |
Petach Tiqva, Israel, 49100 |
Principal Investigator: | Eyal Fenig, M.D. | Rabin Medical Center |
Study ID Numbers: | 004253 |
Study First Received: | March 7, 2007 |
Last Updated: | March 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00445250 History of Changes |
Health Authority: | Israel: Ministry of Health |
Calcipotriol Breast Cancer Radiotherapy Radiodermatitis in Breast Cancer |
Calcipotriene Skin Diseases Wounds and Injuries Disorders of Environmental Origin |
Radiodermatitis Breast Neoplasms Radiation Injuries Dermatitis |
Calcipotriene Skin Diseases Therapeutic Uses Wounds and Injuries Disorders of Environmental Origin |
Radiodermatitis Dermatologic Agents Pharmacologic Actions Radiation Injuries Dermatitis |