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

University of Limoges (UL)

Status: Completed

Conditions: Radiation Dermatitis

Treatments: Drug: Trixiera; Drug: Evoskin

Study type: Interventional

Funder types: Other

Identifiers

NCT02334345

I13026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

EVOSKIN

Experimental group

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.

Treatment:

Drug: Evoskin

TRIXIERA

Active Comparator group

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.

Treatment:

Drug: Trixiera