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Not yet recruitingNCT07869186ReGeneraUpdated Oct 9, 2026

Dermatological Effects and Quality of Life in Oncology Patients

An interventional study of skin barrier assessment in Breast Cancer, Ovarian Cancer and NSCLC (Non-small Cell Lung Cancer), sponsored by European Institute of Oncology. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by European Institute of Oncology · Not applicable, Interventional, and Diagnostic

Updated Oct 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Breast Cancer
  • Ovarian Cancer
  • NSCLC (Non-small Cell Lung Cancer)
  • Melanoma (Skin Cancer)
  • Gynecological Cancer

Keywords

  • dermatological
  • oncology patient
  • TEWL
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 300 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

European Institute of Oncology is the lead sponsor of 184 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
    • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    skin barrier integrity assessment

    Diagnostic Test: skin barrier assessment

Interventions

  • Diagnostic testskin barrier assessment

    Assessment of skin barrier integrity, quantified by transepidermal water loss (TEWL) measured under standardized conditions

06

What researchers measure

Primary outcomes

  1. transepidermal water loss (TEWL)

    Time frame: Difference between baseline value and 6-month follow-up value

07

Study locations

1 site
  • European Institute of Oncology
    Milan, Italy 20141, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 9, 2026
Show all 1 update
  1. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869186
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 12, 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Oct 9, 2026

Study contacts

Dario Trapani, MD
Contact
dario.trapani@ieo.it
0257489267

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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