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

NCT06474988 | Recruiting

• 1 other identifier: L2-094
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Estrogen Receptor Positive Tumor

Keywords

Estrogen Receptor Positive Breast Cancer; Adjuvant Treatment; Skin Toxicity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Tamoxifen

Patients who are receiving treatment with tamoxifen in adjuvant setting

Other: Skin tests

Aromatase Inhibitors

Patients who are receiving treatment with an aromatase inhibitor in adjuvant setting

Other: Skin tests

Paclitaxel

Patients who are receiving treatment with Paclitaxel in adjuvant setting

Other: Skin tests

Interventions

Skin tests OTHER

Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests

Aromatase Inhibitors; Paclitaxel; Tamoxifen

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Skin Tests

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Giulio Tosti, MD

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giulio Tosti, MD

CONTACT

+39 0257489318; giulio.tosti@ieo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: May 27, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

IT (1)