Dermatological Effects and Quality of Life in Oncology Patients

NCT07869186 | Not Yet Recruiting

• 2 other identifiers: UID 5349L2-624
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

dermatological; oncology patient; TEWL

Outcome Measures

Primary Outcomes (1)

• transepidermal water loss (TEWL)

  Difference between baseline value and 6-month follow-up value

Study Arms (1)

skin barrier integrity assessment

EXPERIMENTAL

Diagnostic Test: skin barrier assessment

Interventions

skin barrier assessment DIAGNOSTIC_TEST

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

skin barrier integrity assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Central Study Contacts

Dario Trapani, MD

CONTACT

0257489267; dario.trapani@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 12, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)