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

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer; Non-Small-Cell Lung Carcinoma
• Interventions: Drug: Diprosone

• Registration Number: NCT00910676
• Lead Sponsor: Centre Oscar Lambret

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-05-29
• Study First Posted: 2009-06-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-30
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DIPROSONE	Diprosone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Hospitalier Regional; 🇫🇷 Lille, France

Centre Hospitalier Régional; 🇫🇷 Lille, France