Skin Protection During Radiotherapy in Patients With Breast Cancer

Not Applicable

Completed

• Conditions: Radiation Dermatitis
• Interventions: Drug: Evoskin; Drug: Trixiera

• Registration Number: NCT02334345
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Study First Submitted: 2014-12-16
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-06
• Study First Posted: 2015-01-08
• Primary Completion: 2015-11-01
• Study Completion: 2021-01-17
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-27
• Last Update Posted: 2022-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVOSKIN	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.
TRIXIERA	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.

Primary Outcome Measures

Name	Time	Method
Average of the radiation dermatitis intensity	at 3 months	Radiation dermatitis will be assessed by means of a spectrophotometer after the patient has received 50Gy

Secondary Outcome Measures

Name	Time	Method
Clinical grade of dermatitis	at 3 months	dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy

Trial Locations

Locations (1)

CHU LIMOGES - Radiothérapie; 🇫🇷 Limoges, France