Understanding skin changes in breast cancer patients during treatment
Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.
This study looks at how hormone treatments for breast cancer affect the skin of patients to find better ways to prevent and manage skin problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT06474988 on ClinicalTrials.gov |
What this trial studies
This observational study aims to characterize the chemical, physical, and structural parameters of the skin in patients with estrogen receptor positive breast cancer who are undergoing adjuvant treatment. The focus is on understanding how to prevent and manage adverse skin events associated with hormone therapy, particularly those caused by treatments like Tamoxifen, Aromatase Inhibitors, and Paclitaxel. By performing specific skin tests with professional instruments, the study seeks to gather data that could inform the development of new functional dermocosmetics to alleviate skin toxicity. The research will also consider the impact of combined therapies, including radiotherapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 70 years with estrogen receptor positive breast cancer currently receiving adjuvant hormone therapy or chemotherapy.
Not a fit: Patients with pre-existing chronic skin conditions or those unable to comply with the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of skin toxicity in breast cancer patients, enhancing their treatment adherence and overall outcomes.
How similar studies have performed: While there have been studies on skin toxicity in cancer treatments, this specific approach focusing on biophysical skin parameters in conjunction with hormone therapy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Giulio Tosti, MD — European Istitute of Oncology
- Study coordinator: Giulio Tosti, MD
- Email: giulio.tosti@ieo.it
- Phone: +39 0257489318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.