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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of Onco-Rash cream | Drug | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julien PERON, MD | Contact | 478862339 | +33 | julien.peron@chu-lyon.fr |
| Anne-Sophie BELMONT | Contact | 0478864195 | +33 | anne-sophie.belmont@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julien PERON, MD | Institut de Cancérologie des Hospices Civils de Lyon - Service d'Oncologie médicale | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie des Hospices Civils de Lyon - Service Oncologie Médicale - Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
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|
| Application of Onco-Neutre cream | Drug | 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. |
|
| 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. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D005076 | Exanthema |
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |
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