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

Not Applicable

• Conditions: Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Head and Neck Neoplasms
• Interventions: Drug: Application of Onco-Rash cream; Drug: Application of Onco-Neutre cream

• Registration Number: NCT04878692
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Last Update Submitted: 2021-05-04
• Study First Posted: 2021-05-07
• Last Update Posted: 2021-05-07
• Study Start: 2021-06-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Onco-Rash arm	Application of Onco-Rash cream	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.
Onco-Neutre arm	Application of Onco-Neutre cream	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France