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Tracking Information | |||||||||
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First Received Date † | March 7, 2007 | ||||||||
Last Updated Date | March 7, 2007 | ||||||||
Start Date † | |||||||||
Current Primary Outcome Measures † |
Prevention of radiodermatitis | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
Side effects of Calcipotriol | ||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | The Role of Calcipotriol as Radioprotector of Skin | ||||||||
Official Title † | Phase 2 Study of the Role of Calcipotriol as Radioprotector of Skin in Women Receiving Radiotherapy Treatment to the Breast. | ||||||||
Brief Summary | 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. |
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Detailed Description | 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:
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
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Radiodermatitis | ||||||||
Intervention † | Drug: Calcipotriol | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Not yet recruiting | ||||||||
Enrollment † | 50 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years to 75 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | Israel | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00445250 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Rabin Medical Center | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | Rabin Medical Center | ||||||||
Verification Date | January 2007 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |