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This is a randomized study, mepitel vs standard of care for the prevention and skin toxicity due to radiotherapy in patients with post-surgery breast cancer.
Mepitel film will be placed on the skin of the patients just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of toxicities.
For patients randomized in the mepitel arm:
Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with mepitel.
For patients randomized in the standard of treatment arm:
Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine o Ialugen Plus) cream in case of skin erythema. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mepitel Film | Experimental | Mepitel film will be placed on the patients' skin just before the start of the radiotherapy and will be replaced once a week until the end of the radiotherapy. In case of skin toxicities mepitel film will be placed until resolution of the toxicities. In case of new skin toxicities appearance the patient will be retreated with Mepitel. |
|
| Excipial U hydrolotion, Flammazin skin cream | Active Comparator | Patients will be treated with aqueous (Excipial U hydrolotion) or antiseptic (Flammazine or Ialugen Plus) cream in case of skin erythema due to radiotherapy. In case of new skin toxicities appearance the patient will be retreated with standard of care treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mepitel Film | Device | Placement of Mepitel Film to prevent skin toxicity |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE) | Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity | one week after start of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Time for the skin toxicity appearance and resolution | one week after start of radiotherapy | |
| Severity of the chronic skin toxicity | Common Terminology Criteria for Adverse Events (CTCAE) v.4 | one week after start of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dario Valcarenghi | Oncology Institute of Southern Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Institute of Southern Switzerland | Bellinzona | 6500 | Switzerland | |||
| Institut für Radiotherapie Klinik Hirslanden |
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| ID | Term |
|---|---|
| D063465 | Skin Cream |
| ID | Term |
|---|---|
| D017592 | Skin Care |
| D006920 | Hygiene |
| D013812 | Therapeutics |
| D003358 | Cosmetics |
| D006795 |
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| skin cream |
| Drug |
cream to treat skin erythema due to radiotherapy |
|
|
| Zurich |
| 8032 |
| Switzerland |
| Household Products |
| D013676 | Technology, Industry, and Agriculture |