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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06474988
Enrollment
150
Registered
2024-06-26
Start date
2024-05-27
Completion date
2025-05-31
Last updated
2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Estrogen Receptor Positive Tumor

Keywords

Estrogen Receptor Positive Breast Cancer, Adjuvant Treatment, Skin Toxicity

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.

Interventions

Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Effects of Skin Disease on Quality of Life1 dayCollection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Forearm hydration degree assessmnent1 dayForearm hydration degree evaluated using instrumental skin tests

Countries

Italy

Contacts

Primary ContactGiulio Tosti, MD
giulio.tosti@ieo.it+39 0257489318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026