Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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