Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies (OPERA)
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Head and Neck Neoplasms
About this trial
This is an interventional prevention trial for Carcinoma, Non-Small-Cell Lung focused on measuring Skin Rash, anti-EGFR therapy, Cosmetic Product, Acne, Cancer patients
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.
Sites / Locations
- Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Onco-Rash arm
Onco-Neutre arm
In this arm label, patients will apply the Onco-Rash cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. This arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.
In this arm label, patients will apply the Onco-Neutre cream on selected zones (face, neck, thorax,…) twice a day, during 6 weeks. Onco-Neutral cream will be used as an experimental comparator to Onco-Rash cream. This arm will be compared to the Onco-Neutral arm, in which the Onco-Neutral cream will be applied on selected zones (face, neck, thorax,…) twice a day, during 6 weeks.