Skin Protection During Radiotherapy in Patients With Breast Cancer: A Comparative Study of Evoskin® Verus Trixéra®
Overview
- Phase
- Not Applicable
- Intervention
- Evoskin
- Conditions
- Radiation Dermatitis
- Sponsor
- University Hospital, Limoges
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Average of the radiation dermatitis intensity
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: Evoskin
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.
Intervention: Trixiera
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Clinical grade of dermatitis(at 3 months)