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NCT06474988 | RECRUITING | Breast Cancer

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

European Institute of Oncology

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.

Condition or disease

Breast Cancer

Estrogen Receptor Positive Tumor

Intervention/treatment

Skin tests

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 150 participants
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.
Actual Study Start Date : 2024-05-27
Estimated Primary Completion Date : 2025-05-31
Estimated Study Completion Date : 2025-05-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients

Location Details

NCT06474988

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How to Participate

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Locations

RECRUITING

Italy,

European Institute of Oncology

Milan, Italy, 20141