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

June 30, 2022 updated by: Dario Valcarenghi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Oncology Institute of Southern Switzerland
      • Zürich, Switzerland, 8032
        • Institut für Radiotherapie Klinik Hirslanden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Mepitel Film
Placement of Mepitel Film to prevent skin toxicity
Active Comparator: Excipial U hydrolotion, Flammazin 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.
Drug: skin cream
cream to treat skin erythema due to radiotherapy
Other Names:
  • Excipial U hydrolotion, Flammazin

What is the study measuring?

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)
Time Frame: one week after start of radiotherapy
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
Time Frame: one week after start of radiotherapy
one week after start of radiotherapy
Severity of the chronic skin toxicity
Time Frame: one week after start of radiotherapy
Common Terminology Criteria for Adverse Events (CTCAE) v.4
one week after start of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dario Valcarenghi

Investigators

  • Study Chair: Dario Valcarenghi, Oncology Institute of Southern Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Actual)

July 5, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • IOSI-INF-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

not foreseen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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