Breast CancerReGeneraNCT07869186
Dermatological Effects and Quality of Life in Oncology Patients
A study testing skin barrier assessment in people with Breast Cancer and Ovarian Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This is a monocentric, low-risk interventional study designed to characterize established treatment-related dermatologic toxicity in patients receiving systemic anticancer therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Ovarian Cancer, NSCLC (Non-small Cell Lung Cancer)
- What is being tested?
- skin barrier assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2026to Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older.
- Patients receiving active systemic anticancer therapy with at least one of the following drug classes/regimens:
- Taxanes (e.g., paclitaxel, docetaxel) breast cancer or ovarian cancer.
- Neoadjuvant Pembrolizumab for stage III NSCLC
- Ipilimumab + nivolumab neoadjuvant for stage III and first-line metastatic treatment for patients with PD-L1 < 1% or asymptomatic brain metastases, or after progression on BRAF and MEK inhibitors in melanoma.
- Nivolumab and Pembrolizumab in the adjuvant setting from stage IIB to stage III post-surgery in melanoma.
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- Adjuvant Nivolumab also in stage IV NED (No Evidence of Disease) in melanoma.
- Ipilimumab in metastatic melanoma with progression on anti-PD1 therapy.
- Pembrolizumab, Nivolumab and Atezolizumab for Metastatic Non-Small Cell Lung Cancer (NSCLC), breast cancer and gynecological cancer
- Osimertinib: Adjuvant therapy in patients with common activating EGFR mutations for Non-Small Cell Lung Cancer (NSCLC) Amivantamab for advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
- Pegylated liposomal doxorubicin for gynecological cancer
- Presence at enrollment of clinically documented treatment-related dermatologic toxicity involving skin and/or hair and/or nails, defined as:
- CTCAE v5.0 grade ≥1 for at least one pre-specified dermatologic event (e.g., rash, pruritus, xerosis, erythema, pigmentary alteration, photosensitivity, paronychia/onycholysis/nail dystrophy, alopecia) as assessed by the investigators and/or Dermatology-confirmed treatment-related toxicity when CTCAE categorization is not fully applicable (e.g., specific nail morphology patterns).Patients must have been on the current systemic regimen for ≥1 months and ≤12 months at the time of study entry.
- Ability and willingness to undergo instrumental skin assessments under standardized conditions.
- Patients who provide written informed consent
Who cannot join
- Pre-existing chronic dermatologic disease likely to confound assessment of treatment-related toxicity (e.g., psoriasis, atopic dermatitis/eczema, lupus, chronic urticaria), unless clinically inactive and deemed non-confounding by the investigator/dermatologist.
- Active skin infection at the assessment site (bacterial, viral, fungal) that may alter barrier measures.
- Any medical or dermatologic condition that, in the investigator's judgment, may confound assessment of treatment-related skin toxicity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
European Institute of Oncology
Milan, Italy, 20141
Dario Trapani, MD, 0257489267, dario.trapani@ieo.it
About this study
Official title: Evaluation of Skin Alterations and Epidermal Barrier Integrity in Patients Undergoing Pharmacological Cancer Treatments (EOSIN) and Wellbeing Oncological Survey (WOS): an Integrated Approach to Assessing Dermatological Effects and Quality of Life in Oncology Patients
This is a monocentric, low-risk interventional study designed to characterize established treatment-related dermatologic toxicity in patients receiving systemic anticancer therapies. The study will not modify or influence oncologic treatment decisions but will perform standardized instrumental and clinical dermatologic assessments during the course of routine cancer care.
- Conditions
- Breast Cancer, Ovarian Cancer, NSCLC (Non-small Cell Lung Cancer), Melanoma (Skin Cancer), Gynecological Cancer
- Being tested
- skin barrier assessment
- Keywords
- dermatological, oncology patient, TEWL
- Medical subject headings
- Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin barrier assessmentDiagnostic test
Assessment of skin barrier integrity, quantified by transepidermal water loss (TEWL) measured under standardized conditions
| Study group | Role | What they receive |
|---|---|---|
| skin barrier integrity assessment | Experimental | Not described Receives: Diagnostic Test: skin barrier assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
transepidermal water loss (TEWL)
Measured: Difference between baseline value and 6-month follow-up value
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start12 Oct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869186
- Sponsor's protocol ID
- UID 5349
- Other IDs
- L2-624
- Acronym
- ReGenera
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No