Skin Protection During Radiotherapy in Patients With Breast Cancer

Radiation Dermatitis Clinical Trial

— EVOSKIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02334345
• Other study ID #: I13026
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 17, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 17, 2021
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

Drug:
• Evoskin
Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
• Trixiera
Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions

Locations

Country	Name	City	State
France	CHU LIMOGES - Radiothérapie	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average of the radiation dermatitis intensity	Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy	at 3 months
Secondary	Clinical grade of dermatitis	dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy	at 3 months