Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients
Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Giulio Tosti, MD
- Phone Number: +39 0257489318
- Email: giulio.tosti@ieo.it
Study Locations
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-
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Milan, Italy, 20141
- Recruiting
- European Institute of Oncology
-
Contact:
- Giulio Tosti, MD
- Phone Number: +39 0257489318
- Email: giulio.tosti@ieo.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Tamoxifen
Patients who are receiving treatment with tamoxifen in adjuvant setting
|
Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests
|
|
Aromatase Inhibitors
Patients who are receiving treatment with an aromatase inhibitor in adjuvant setting
|
Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests
|
|
Paclitaxel
Patients who are receiving treatment with Paclitaxel in adjuvant setting
|
Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forearm hydration degree assessmnent
Time Frame: 1 day
|
Forearm hydration degree evaluated using instrumental skin tests
|
1 day
|
|
Evaluation of Effects of Skin Disease on Quality of Life
Time Frame: 1 day
|
Collection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Giulio Tosti, MD, European Istitute of Oncology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L2-094
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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