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.

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Estrogen Receptor Positive Tumor
• Intervention / Treatment: Other: Skin tests

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: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Giulio Tosti, MD; Phone Number: +39 0257489318; Email: giulio.tosti@ieo.it

Study Locations

• Italy
  • 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: No

• Sampling Method: Non-Probability Sample

Study Population

Estrogen receptor (ER) positive breast cancer patients undergoing adjuvant therapy

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tamoxifen; Patients who are receiving treatment with tamoxifen in adjuvant setting	Other: Skin tests; 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	Other: Skin tests; Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests
Paclitaxel; Patients who are receiving treatment with Paclitaxel in adjuvant setting	Other: Skin tests; 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	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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Giulio Tosti, MD, European Istitute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: June 20, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Adjuvant Treatment; Estrogen Receptor Positive Breast Cancer; Skin Toxicity
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: L2-094

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No