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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVOSKIN | Experimental | 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. |
|
| TRIXIERA | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoskin | Drug | Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre CLAVRE, MD | CHU LIMOGES | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU LIMOGES - Radiothérapie | Limoges | 87000 | France |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| Trixiera | Drug | Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions |
|
| D014947 |
| Wounds and Injuries |