NCT06474988

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Cancer
• Estrogen Receptor Positive Tumor

Interventions

Type	Name	Description
OTHER	Skin tests	Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests

Timeline

• Start date: 2024-05-27
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-06-26
• Last updated: 2024-06-26

Locations

1 site across 1 country: Italy