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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.
Breast cancer is the most frequent neoplasm in women in industrialized countries. After surgery, an adjuvant systemic treatment is generally proposed (hormone therapy, chemotherapy, molecular targeted therapy).
Side effects of endocrine treatments, including skin toxicities, are frequent and often underestimated, leading to poor treatment adherence that can compromise therapeutic outcomes. Among adjuvant chemotherapy treatments, one of the most used drug is Paclitaxel: at skin level it can induce rash, dry skin and itching.
The combination of radiotherapy with these oncological treatments could aggravate cutaneous side effects.
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patints with breast cancer undergoing adjuvant treatment, performing specific skin tests with professional instruments and adequate personnel. The evaluation will be carried out in Estrogen Receptor (ER) positive breast cancer patients undergoing adjuvant therapy with Tamoxifen or Aromatase Inhibitor or Paclitaxel +/- adjuvant radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Patients who are receiving treatment with tamoxifen in adjuvant setting |
| |
| Aromatase Inhibitors | Patients who are receiving treatment with an aromatase inhibitor in adjuvant setting |
| |
| Paclitaxel | Patients who are receiving treatment with Paclitaxel in adjuvant setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin tests | Other | Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forearm hydration degree assessmnent | Forearm hydration degree evaluated using instrumental skin tests | 1 day |
| 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) | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Estrogen receptor (ER) positive breast cancer patients undergoing adjuvant therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giulio Tosti, MD | Contact | +39 0257489318 | giulio.tosti@ieo.it |
| Name | Affiliation | Role |
|---|---|---|
| Giulio Tosti, MD | European Istitute of Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| European Institute of Oncology | Recruiting | Milan | 20141 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012882 | Skin Tests |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |