Mepitel Film Treatment for the Prevention and Cutaneous Toxicity Due to Radiotherapy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mepitel Film vs Standard of Care for the Radiotherapy Prevention and Cutaneous Toxicity in Patients With Post-surgery Breast Cancer

Conditions
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Post-surgery Radiotherapy

Intervention / Treatment
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* Device: Mepitel Film
* Drug: skin cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with breast cancer treated with conservative surgery who need radiotherapy treatment capability and willness to participate to the study informed consent form signature Exclusion Criteria: contraindication to the correct placement of the Mepitel Film previous breast radiation treatment participating in other clinical trials previous breast reconstruction concomitant treatment with antiblastic chemotherapy

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepitel Film<br>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. | Device: Mepitel Film<br>* Placement of Mepitel Film to prevent skin toxicity<br>|
| Active Comparator: Excipial U hydrolotion, Flammazin skin cream<br>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. | Drug: skin cream<br>* cream to treat skin erythema due to radiotherapy<br>* Other names: Excipial U hydrolotion, Flammazin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |