Carcinoma, Non-Small-Cell LungOPERANCT04878692
Evaluation of a Cosmetic Product to Preserve Skin Conditions When Using Anti-EGFR Cancer Therapies
A study testing Application of Onco-Rash cream and Application of Onco-Neutre cream in people with Carcinoma, Non-Small-Cell Lung and Colorectal Neoplasms, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Head and Neck Neoplasms
- What is being tested?
- Application of Onco-Rash cream and Application of Onco-Neutre cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Julien PERON, MD, 478862339 ext. +33, julien.peron@chu-lyon.fr
Anne-Sophie BELMONT, 478864195 ext. +33, anne-sophie.belmont@chu-lyon.fr
About this study
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
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.
- Being tested
- Application of Onco-Rash cream, Application of Onco-Neutre cream
- Keywords
- Skin Rash, anti-EGFR therapy, Cosmetic Product, Acne, Cancer patients
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Head and Neck Neoplasms, Exanthema, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Onco-Rash creamDrug
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 creamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Onco-Rash arm | Experimental | 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. Receives: Drug: Application of Onco-Rash cream |
| Onco-Neutre arm | Placebo comparator | 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. Receives: Drug: Application of Onco-Neutre cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after the start of the anti-EGFR treatment.
Secondary outcomes (3)
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.
Measured: 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
Measured: 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
Measured: 6 weeks after the start of the anti-EGFR treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien PERON, MD, Principal investigator, Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878692
- Sponsor's protocol ID
- 69HCL20_0519
- Acronym
- OPERA
- Status last verified
- May 2021
- First submitted
- 4 May 2021
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04878692
- Acronym / sponsor ID
- OPERA / 69HCL20_0519
- Keywords
- Skin Rash, anti-EGFR therapy, Cosmetic Product, Acne, Cancer patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onco-Rash arm | Experimental | Drug: Application of Onco-Rash creamIn 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 | Placebo comparator | Drug: Application of Onco-Neutre creamIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,…)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of Onco-Rash creamThe 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. | Drug | Onco-Rash arm |
| Application of Onco-Neutre creamThe 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. | Drug | Onco-Neutre arm |
Primary outcome
Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale).
Time frame: 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.
3 secondary outcomes
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.
Time frame: 6 weeks after the start of the anti-EGFR treatment.
Percentage of patients with a grade 1, 2 or ≥ 2 skin eruption
Time frame: 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
Time frame: 6 weeks after the start of the anti-EGFR treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien PERON, MD principal investigator
Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Onco-Rash cream and Application of Onco-Neutre cream in people with Carcinoma, Non-Small-Cell Lung and Colorectal Neoplasms, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien PERON, MD (478862339 ext. +33, julien.peron@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the percentage of Onco-Rash failure by counting the number of patients with a rash grade ≥ 2 (NCI-CTCAE scale). (time frame: 6 weeks after the start of the anti-EGFR treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.