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

NCT ID: NCT06474988

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-27
• Study Completion Date: 2025-05-31

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.

Conditions

Breast Cancer; Estrogen Receptor Positive Tumor

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Tamoxifen

Patients who are receiving treatment with tamoxifen in adjuvant setting

Skin tests

Intervention Type: OTHER

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

Skin tests

Intervention Type: OTHER

Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests

Paclitaxel

Patients who are receiving treatment with Paclitaxel in adjuvant setting

Skin tests

Intervention Type: OTHER

Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests

Interventions

Skin tests

Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giulio Tosti, MD

Role: PRINCIPAL_INVESTIGATOR

European Istitute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giulio Tosti, MD

Role: CONTACT

giulio.tosti@ieo.it

+39 0257489318

Facility Contacts

Giulio Tosti, MD

Role: primary

giulio.tosti@ieo.it

+39 0257489318

Other Identifiers

L2-094

Identifier Type: -

Identifier Source: org_study_id