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Completed

NCT Number: NCT00910676

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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-Small-Cell Lung Carcinoma Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Regional, Lille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diprosone

Drug
  • 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

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib

    Time frame: 2 months of treatment

  2. To list the cutaneous side effects of the EGF-R inhibitors

    Time frame: 2 months of treatment

  3. To assess the patient quality of life with the DLQI questionnaire

    Time frame: 2 months of treatment

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study 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 Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib

Acronym: DIPROCOL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 1, 2009
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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