Back to resultsSkin Protection During Radiotherapy in Patients With Breast Cancer (EVOSKIN)
Primary Purpose
Radiation Dermatitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Evoskin
Trixiera
Sponsored by
About this trial
This is an interventional prevention trial for Radiation Dermatitis
Eligibility Criteria
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
Sites / Locations
- CHU LIMOGES - Radiothérapie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EVOSKIN
TRIXIERA
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Average of the radiation dermatitis intensity
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
Secondary Outcome Measures
Clinical grade of dermatitis
dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy
Full Information
NCT ID
NCT02334345
First Posted
December 16, 2014
Last Updated
February 27, 2022
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT02334345
Brief Title
Skin Protection During Radiotherapy in Patients With Breast Cancer
Acronym
EVOSKIN
Official Title
Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 1, 2015 (Actual)
Study Completion Date
January 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Dermatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EVOSKIN
Arm Type
Experimental
Arm Description
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.
Arm Title
TRIXIERA
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Evoskin
Intervention Description
Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
Intervention Type
Drug
Intervention Name(s)
Trixiera
Intervention Description
Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
Primary Outcome Measure Information:
Title
Average of the radiation dermatitis intensity
Description
Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Clinical grade of dermatitis
Description
dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy
Time Frame
at 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre CLAVRE, MD
Organizational Affiliation
CHU LIMOGES
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU LIMOGES - Radiothérapie
City
Limoges
ZIP/Postal Code
87000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Skin Protection During Radiotherapy in Patients With Breast Cancer
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