Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorEuropean Institute of Oncology
About this trial
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional dermocosmetics.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 40 and 70 years
subjects who are receiving treatment with tamoxifen, aromatase inhibitor or paclitaxel in adjuvant therapy +/- adjuvant radiotherapy
subjects who are receiving hormonal therapy must have suspended any chemotherapy for at least 30 days
Disqualifiers
presence of known chronic skin pathologies before adjuvant treatment start (psoriasis, lupus, atopic dermatitis)
inability to understand and will
unavailability to carry out all the tests required by the protocol
Trial population
Estrogen receptor (ER) positive breast cancer patients undergoing adjuvant therapy
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Skin tests
Other interventionAcquisition of Skindex questionnaire 29 and execution of instrumental skin tests
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Tamoxifen1 intervention
Group B: Aromatase Inhibitors1 intervention
Group C: Paclitaxel1 intervention
Trial outcomes
Primary outcomes
1
Forearm hydration degree assessmnent
Forearm hydration degree evaluated using instrumental skin tests
Time frame
1 day2
Evaluation of Effects of Skin Disease on Quality of Life
Collection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov