Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients

Recruiting

• Conditions: Breast Cancer; Estrogen Receptor Positive Tumor
• Interventions: Other: Skin tests

• Registration Number: NCT06474988
• Lead Sponsor: European Institute of Oncology

Brief 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.

Study Timeline

• Study Start: 2024-05-27
• Status Verified: 2024-06
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tamoxifen	Skin tests	Patients who are receiving treatment with tamoxifen in adjuvant setting
Aromatase Inhibitors	Skin tests	Patients who are receiving treatment with an aromatase inhibitor in adjuvant setting
Paclitaxel	Skin tests	Patients who are receiving treatment with Paclitaxel in adjuvant setting

Primary Outcome Measures

Name	Time	Method
Forearm hydration degree assessmnent	1 day	Forearm hydration degree evaluated using instrumental skin tests
Evaluation of Effects of Skin Disease on Quality of Life	1 day	Collection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy