Breast Cancer, Radiation Dermatitis
Conditions
Brief summary
The primary objective consisted of avoiding deterioration and/or restoring the integrity of the skin of patients treated by radiotherapy, right from the first signs of grade 1 or 2 radiation dermatitis.
Interventions
DEVICECastalie water spray
DEVICEHydrogel Hydrosorb®
Sponsors
Paul Hartmann
Institut Curie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women treated by normo fractionated radiotherapy for breast cancer * Presenting grade 1 or 2 radiation dermatitis during the treatment and who provided their written informed consent were included in the study.
Exclusion criteria
* Were male patients * Radiation dermatitis already treated or caused by another treatment * Subjects deprived of their freedom or under guardianship * Subjects in whom medical follow-up was impossible * A cancer wound or skin flap on the irradiated zone * A history of allergic skin reaction * Concomitant chemotherapy or concomitant bevacizumab therapy and bilateral irradiation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| local treatment failure defined as interruption of radiotherapy because of skin radiotoxicity or change of local care because skin alteration. | through study completion, an average of 3 years |
Secondary
| Measure | Time frame |
|---|---|
| skin colorimetry measured by a colorimeter | day0, day 7, day 14, day 21, day 28 |
| pain level assessed by the visual analog pain scale | day0, day 7, day 14, day 21, day 28 |
| quality of life assessed with the Dermatology Life Quality Index questionnaire | day0, day 14, day 28 |
Countries
France
Outcome results
None listed