Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors

Study Overview
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Brief Summary
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Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.

Official Title
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Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib

Conditions
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Metastatic Colorectal Cancer, Non-Small-Cell Lung Carcinoma

Intervention / Treatment
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* Drug: Diprosone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication of Cetuximab in patients with metastatic colorectal cancer in association or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma, after failure of at least one chemotherapy treatment No pre-existing cutaneous toxicity Exclusion Criteria: Contraindication to local corticotherapy Previous history of severe hypersensibility reactions (Grade III or IV) due to Cetuximab, Irinotecan or Erlotinib Betamethasone or one of excipient product allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DIPROSONE<br> | Drug: Diprosone<br>* Start of treatment: as soon as the EGF-R inhibitors treatment begins Application: On the body area susceptible to be affected by folliculitis, once a day, in the evening Dosage: Quantity corresponded to around 2 tubes of 30 grams a week on the face, the chest and upper side of the back. There is no maximum dosage. Period of treatment: 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began |  | 2 months of treatment by corticotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib |  | 2 months of treatment | 
| To list the cutaneous side effects of the EGF-R inhibitors |  | 2 months of treatment | 
| To assess the patient quality of life with the DLQI questionnaire |  | 2 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EGF-R inhibitors