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

Dario Valcarenghi164 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

164

Conditions

Post-surgery Radiotherapy

Interventions

Mepitel FilmDEVICE

Placement of Mepitel Film to prevent skin toxicity

skin creamDRUG

cream to treat skin erythema due to radiotherapy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Oncology Institute of Southern Switzerland

Bellinzona, Switzerland

Institut für Radiotherapie Klinik Hirslanden

Zurich, Switzerland

Outcomes

Primary Outcomes

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

Time frame: one week after start of radiotherapy

Secondary Outcomes

Time for the skin toxicity appearance and resolution

Time frame: one week after start of radiotherapy

Severity of the chronic skin toxicity

Common Terminology Criteria for Adverse Events (CTCAE) v.4

Time frame: one week after start of radiotherapy

Data from ClinicalTrials.gov

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