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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Application of Onco-Rash cream

Application of Onco-Neutre cream

About this trial

This is an interventional prevention trial for Carcinoma, Non-Small-Cell Lung focused on measuring Skin Rash, anti-EGFR therapy, Cosmetic Product, Acne, Cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Onco-Rash arm

Onco-Neutre arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

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

Full Information

NCT ID

NCT04878692

First Posted

May 4, 2021

Last Updated

May 4, 2021

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT04878692

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Anticipated)

Primary Completion Date

July 1, 2022 (Anticipated)

Study Completion Date

July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Skin Rash, anti-EGFR therapy, Cosmetic Product, Acne, Cancer patients

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Onco-Rash arm

Arm Type

Experimental

Arm Description

Arm Title

Onco-Neutre arm

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Application of Onco-Rash cream

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Application of Onco-Neutre cream

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale).

Description

Time Frame

6 weeks after the start of the anti-EGFR treatment.

Secondary Outcome Measure Information:

Title

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.

Description

Comparison of timing of apparition of grade 1, 2 or ≥ 2 skin eruption between the Onco-Rash arm and the Onco-Neutral arm.

Time Frame

6 weeks after the start of the anti-EGFR treatment.

Title

Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption

Description

Number of patients for whom a grade 1, 2 or ≥ 2 skin eruption have been reported

Time Frame

6 weeks after the start of the anti-EGFR treatment.

Title

Percentage of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been introduced

Description

Number of patients for whom treatment for acne (anti-inflammatory or antibiotic) has been prescribed

Time Frame

6 weeks after the start of the anti-EGFR treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Julien PERON, MD

Phone

478862339

Ext

+33

julien.peron@chu-lyon.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Anne-Sophie BELMONT

Phone

0478864195

Ext

+33

anne-sophie.belmont@chu-lyon.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julien PERON, MD

Organizational Affiliation

Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud

City

Pierre-Bénite

ZIP/Postal Code

69495

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Julien PERON, MD

Phone

478862339

Ext

+33

julien.peron@chu-lyon.fr

First Name & Middle Initial & Last Name & Degree

Anne-Sophie BELMONT

Phone

478864195

Ext

+33

anne-sophie.belmont@chu-lyon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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