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

Evaluation of a Cosmetic Product (Onco-Rash) to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies Which Are Known to Fragilize Epidermis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms
• Intervention / Treatment: Drug: Application of Onco-Rash cream; Drug: Application of Onco-Neutre cream

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julien PERON, MD; Phone Number: +33 478862339; Email: julien.peron@chu-lyon.fr
• Study Contact Backup: Name: Anne-Sophie BELMONT; Phone Number: +33 0478864195; Email: anne-sophie.belmont@chu-lyon.fr

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud
    • Contact: Julien PERON, MD; Phone Number: +33 478862339; Email: julien.peron@chu-lyon.fr
    • Contact: Anne-Sophie BELMONT; Phone Number: +33 478864195; Email: anne-sophie.belmont@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Onco-Rash 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.	Drug: Application 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.
Placebo Comparator: Onco-Neutre arm; 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.	Drug: Application 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale).	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.	6 weeks after the start of the anti-EGFR treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Comparison of timing of apparition of grade 1, 2 or ≥ 2 skin eruption between the Onco-Rash arm and the Onco-Neutral arm.	6 weeks after the start of the anti-EGFR treatment.
Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption	Number of patients for whom a grade 1, 2 or ≥ 2 skin eruption have been reported	6 weeks after the start of the anti-EGFR treatment.
Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced	Number of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been prescribed	6 weeks after the start of the anti-EGFR treatment.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Julien PERON, MD, Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Acne; Skin Rash; anti-EGFR therapy; Cancer patients; Cosmetic Product
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Neoplasms; Neoplasms; Head and Neck Neoplasms; Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Skin Diseases
• Other Study ID Numbers: 69HCL20_0519

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No