Skin Protection During Radiotherapy in Patients With Breast Cancer

Study Overview
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Brief Summary
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Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

Detailed Description
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Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.

Official Title
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Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Drug: Evoskin
* Drug: Trixiera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or more Patients with breast cancer for which a treatment by radiotherapy is planned No concomitant chemotherapy Signed informed consent Exclusion Criteria: Cutaneous neoplasia radiotherapy Total mastectomy Bilateral breast cancer Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder Pregnant, breast-feeding woman

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVOSKIN<br>Patients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day. | Drug: Evoskin<br>* Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions<br>|
| Active Comparator: TRIXIERA<br>Patients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day. | Drug: Trixiera<br>* Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average of the radiation dermatitis intensity | Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy | at 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical grade of dermatitis | dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy | at 3 months |