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

Carcinoma, Non-Small-Cell Lung Clinical Trial

— OPERA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04878692
• Other study ID #: 69HCL20_0519
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: May 2021
• Source: Hospices Civils de Lyon
• Contact: Julien PERON, MD
• Phone: 478862339
• Email: julien.peron[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Head and Neck Neoplasms
• Neoplasms
• Skin Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.