Skin Protection During Radiotherapy in Patients With Breast Cancer (EVOSKIN)

February 27, 2022 updated by: University Hospital, Limoges

Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®

Radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. Many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. In the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women with breast cancer and were to receive breast radiotherapy to 50 Gy were enrolled in a prospective randomized trial to compare the effectiveness of Evoskin®) for protecting skin compared to Trixiera. To account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. Each patient was randomly assigned to use Evoskin on the half of the irradiated breast and to use the Triexiera on the other half. Dermatitis was graded weekly by means of a spectrophotometer.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • France
      • Limoges, France, 87000
        • CHU LIMOGES - Radiothérapie

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:

  • 18 years old or more
  • Patients with breast cancer for which a treatment by radiotherapy is planned
  • No concomitant chemotherapy
  • Signed informed consent

Exclusion Criteria:

  • Cutaneous neoplasia radiotherapy
  • Total mastectomy
  • Bilateral breast cancer
  • Dark skinDiseases enhancing radiosensitivity Patient with a generalized skin disorder
  • Pregnant, breast-feeding woman

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EVOSKIN
Patients are to apply Evoskin ( topical agent) in the half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.
Drug: Evoskin
Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
Active Comparator: TRIXIERA
Patients are to apply Trixiera ( topical agent) in the other half of the irradiated breast 3 hours after radiothérapy and may be applied again later the same day.
Drug: Trixiera
Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average of the radiation dermatitis intensity
Time Frame: at 3 months
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical grade of dermatitis
Time Frame: at 3 months
dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy
at 3 months

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

Investigators

  • Principal Investigator: Pierre CLAVRE, MD, CHU Limoges

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

January 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

January 17, 2021

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 14, 2022

Last Update Submitted That Met QC Criteria

February 27, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I13026

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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