Clinical trial NCT04878692: Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies
Official title: Evaluation of a Cosmetic Product (Onco-Rash) to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies Which Are Known to Fragilize Epidermis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Head and Neck Neoplasms
Keywords: Skin Rash
anti-EGFR therapy
Cosmetic Product
Acne
Cancer patients
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: It is important for patients treated with anti-EGFR therapies to get access to cosmetic options to preserve their skin condition during treatment. Anti-EGFR therapies are known to fragilize epidermis and to provoke rashes; which often lead to treatment discontinuation.

The aim of this study is to demonstrate that the Onco-Rash cream is able to preserve skin condition without side effects. Decreasing skin toxicity is expected to improve patients' life and facilitate treatment follow-up.


Eligibility criteria: Inclusion Criteria:

* Patient \> 18 years old
* Patient naive from anti-EGFR treatment (gefitinib, erlotinib, afatinib, cetuximab panitumumab, osimertinib, alectinib et crizotinib, etc).
* NSCLC (non-small cell lung cancer) patients eligible to anti-EGFR as first line treatment (gefitinib, erlotinib,afatinib, etc)
* Colorectal cancer patients eligible to anti-EGFR as first line treatment (cetuximab, panitumumab,....)
* Head and Neck/ENT (Ear, Nose Troat) cancer patients eligible to anti-EGFR as first line treatment (cetuximab,...)
* Signed informed consent
* Social security affiliation

Exclusion Criteria:

* Pregnant or Breastfeeding patient
* Patient in age to procreate without an efficient contraceptive method
* Patient with previous experience of allergic or irritative contact dermatitis to components of the studied product
* Patient with dermatologic conditions that cannot permit the study of skin toxicity of anti-EGFR
* Patients under radiotherapy 8 days prior the inclusion date
* Patient under immunotherapy 8 days prior the inclusion date
* Patient with local or systemic antibiotic treatment for acne 8 days prior the inclusion date
* Patient with antihistamines treatment 8 days prior the inclusion date
* Patients taking NSAIDs or corticoids as chronic medication or that took NSAIDs or corticoids 5 days prior the inclusion date
* Participation to another interventional study
* Patient with an altered ECOG (Eastern Cooperative Oncology Group) state ( \>2)
* Patient deprived of liberty or subjected to guardianship
* Impossibility to track and follow patient for geographical, social or psychiatric reasons.

Primary outcomes:
measure: Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale).
timeFrame: 6 weeks after the start of the anti-EGFR treatment.
Secondary outcomes:
measure: Timing of apparition of grade 1, 2 or ≥ 2 skin eruption: number of days between the start of the anti-EGFR treatment and the apparition of a skin eruption.
timeFrame: 6 weeks after the start of the anti-EGFR treatment.
measure: Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption
timeFrame: 6 weeks after the start of the anti-EGFR treatment.
measure: Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced
timeFrame: 6 weeks after the start of the anti-EGFR treatment.
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud
Study officials:
affiliation: Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale
name: Julien PERON, MD
role: PRINCIPAL_INVESTIGATOR
References: