Clinical trial NCT06474988: Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients
Official title: Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Estrogen Receptor Positive Tumor
Keywords: Estrogen Receptor Positive Breast Cancer
Adjuvant Treatment
Skin Toxicity
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Estrogen receptor (ER) positive breast cancer patients undergoing adjuvant therapy

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.

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

Primary outcomes:
measure: Forearm hydration degree assessmnent
timeFrame: 1 day
measure: Evaluation of Effects of Skin Disease on Quality of Life
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Giulio Tosti, MD
role: PRINCIPAL_INVESTIGATOR
References: