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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuxim

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 Summary:
Sponsor: Centre Oscar Lambret

Current Primary Outcome: 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 [ Time Frame: 2 months of treatment by corticotherapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Centre Oscar Lambret

Dates:
Date Received: May 29, 2009
Date Started: October 2007
Date Completion:
Last Updated: July 30, 2012
Last Verified: July 2012