search
Back to results

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
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
May 4, 2021
Last Updated
May 4, 2021
Sponsor
Hospices Civils de Lyon
search

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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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.
Arm Title
Onco-Neutre arm
Arm Type
Placebo Comparator
Arm 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.
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
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.
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
No
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
Email
julien.peron@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Sophie BELMONT
Phone
0478864195
Ext
+33
Email
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
Email
julien.peron@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Anne-Sophie BELMONT
Phone
478864195
Ext
+33
Email
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

We'll reach out to this number within 24 hrs