Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies (OPERA)

Civil Hospices of Lyon

Status: Unknown

Conditions: Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Colorectal Neoplasms

Treatments: Drug: Application of Onco-Neutre cream; Drug: Application of Onco-Rash cream

Study type: Interventional

Funder types: Other

Identifiers

NCT04878692

69HCL20_0519

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 2 patient groups, including a placebo group

Onco-Rash arm

Experimental group

Description:

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.

Treatment:

Drug: Application of Onco-Rash cream

Onco-Neutre arm

Placebo Comparator group

Description:

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.

Treatment:

Drug: Application of Onco-Neutre cream