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

Phase 3

Completed

• Conditions: Post-surgery Radiotherapy
• Interventions: Device: Mepitel Film; Drug: skin cream

• Registration Number: NCT02741258
• Lead Sponsor: Dario Valcarenghi

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.

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mepitel Film	Mepitel Film	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	skin cream	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Institut für Radiotherapie Klinik Hirslanden; 🇨🇭 Zürich, Switzerland