Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474988
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-20
Brief Title:
Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
Official Title:
Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of this study is to characterize the chemicalphysical 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
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 chemicalphysical 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
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 chemicalphysical 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None