Post-surgery Radiotherapy
Conditions
Brief summary
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
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.
Interventions
DEVICEMepitel Film
Placement of Mepitel Film to prevent skin toxicity
DRUGskin cream
cream to treat skin erythema due to radiotherapy
Sponsors
Dario Valcarenghi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mepitel Film efficacy in treating skin toxicity evaluatet with Common Terminology Criteria for Adverse Events (CTCAE) | one week after start of radiotherapy | Common Terminology Criteria for Adverse Events (CTCAE) V.4 will be used to evaluate the toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for the skin toxicity appearance and resolution | one week after start of radiotherapy | — |
| Severity of the chronic skin toxicity | one week after start of radiotherapy | Common Terminology Criteria for Adverse Events (CTCAE) v.4 |
Countries
Switzerland
Outcome results
None listed