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

European Institute of Oncology

Status: Enrolling

Conditions: Breast Cancer; Estrogen Receptor Positive Tumor

Treatments: Other: Skin tests

Study type: Observational

Funder types: Other

Identifiers

NCT06474988

L2-094

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

Tamoxifen

Description:

Patients who are receiving treatment with tamoxifen in adjuvant setting

Treatment:

Other: Skin tests

Aromatase Inhibitors

Description:

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

Treatment:

Other: Skin tests

Paclitaxel

Description:

Patients who are receiving treatment with Paclitaxel in adjuvant setting

Treatment:

Other: Skin tests