Overview
Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-07-01
2022-07-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Hospices Civils de Lyon
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.