Radiation Dermatitis
Conditions
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.
Interventions
DRUGEvoskin
Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
DRUGTrixiera
Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
Sponsors
University Hospital, Limoges
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical grade of dermatitis | at 3 months | dermatitis grade will be assessed according to CTCAE after the patient has received 50 Gy |
Countries
France
Outcome results
None listed