Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Head and Neck Neoplasms
Conditions
Keywords
Skin Rash, anti-EGFR therapy, Cosmetic Product, Acne, Cancer patients
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.
Interventions
DRUGApplication of Onco-Rash cream
The cream Onco-Rash will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.
DRUGApplication of Onco-Neutre cream
The cream Onco-Neutre will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale). | 6 weeks after the start of the anti-EGFR treatment. | Measurement of Onco-Rash percentage of failure by counting the number of patients for whom a skin rash with a grade ≥ 2 (NCI-CTCAE scale) will occur between 0-6 weeks after the start of the anti-EGFR treatment. The introduction of an anti-inflammatory, a calming or an antibiotic treatment for acne will also be considered as failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 6 weeks after the start of the anti-EGFR treatment. | Comparison of timing of apparition of grade 1, 2 or ≥ 2 skin eruption between the Onco-Rash arm and the Onco-Neutral arm. |
| Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption | 6 weeks after the start of the anti-EGFR treatment. | Number of patients for whom a grade 1, 2 or ≥ 2 skin eruption have been reported |
| Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced | 6 weeks after the start of the anti-EGFR treatment. | Number of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been prescribed |
Countries
France
Contacts
Primary ContactJulien PERON, MD
Backup ContactAnne-Sophie BELMONT
Outcome results
None listed