Actively Recruiting

Age: 40Years - 70Years
All Genders
ID06474988

Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.

Led by European Institute of Oncology · Updated on 2024-06-26

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the skin characteristics of patients with breast cancer who are undergoing various adjuvant treatments after surgery. The study focuses on understanding the chemical, physical, and structural changes in the skin to help prevent and manage skin side effects caused by hormone therapy, chemotherapy, and radiotherapy. These skin side effects can affect treatment adherence and outcomes, especially in estrogen receptor positive breast cancer patients receiving Tamoxifen, Aromatase Inhibitors, or Paclitaxel. Participants in this observational study will be grouped based on their treatment: Tamoxifen, Aromatase Inhibitors, or Paclitaxel, with some also receiving radiotherapy. The study involves performing specialized skin tests and using professional instruments to assess skin condition. The tests include questionnaires like the Skindex 29 and instrumental evaluations to monitor skin hydration and other physical properties. During the study, participants will undergo skin assessments and complete quality of life questionnaires related to skin conditions. The primary outcomes measured are forearm skin hydration and the impact of skin disease on quality of life, assessed on a single day. This study aims to provide detailed data on skin changes during breast cancer adjuvant therapy, helping guide future management and development of new dermocosmetic products. The study is set to run until May 2025.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 40Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 40 and 70 years
  • Receiving treatment with tamoxifen, aromatase inhibitor, or paclitaxel in adjuvant therapy with or without adjuvant radiotherapy
  • If receiving hormonal therapy, must have stopped any chemotherapy for at least 30 days
Not Eligible

You will not qualify if you...

  • Presence of known chronic skin diseases before starting adjuvant treatment such as psoriasis, lupus, or atopic dermatitis
  • Inability to understand and give consent
  • Unavailability to complete all required tests according to the study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Observational Assessment

Duration - 1 day

Participants undergo skin tests and complete questionnaires to characterize skin parameters during their adjuvant treatment for breast cancer.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

European Institute of Oncology

Milan, Italy, 20141

Actively Recruiting

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Research Team

G

Giulio Tosti, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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