Cancer patients experiencing folliculitis due to treatment with cetuximab MedDRA version: 12.0 Level: LLT Classification code 10061451 Term: Colorectal cancer MedDRA version: 12.0 Level: LLT Classification code 10067821 Term: Head and neck cancer
Conditions
Interventions
Product Name: Menadione Nicotinamide Bisulfite
Product Code: 50 0615 5
Pharmaceutical Form: Cream
INN or Proposed INN: 2-methyl-1.4-naphtoquinone pyridin-3-carboxylic acid amide bisulfite
CAS Number:
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Planned or ongoing treatment with cetuximab. - Age at least 18 years old. - Informed consent according to local and national legislation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - No known disease which can influence treatment, evaluation and the outcome of the current disease and treatment - including chronic diseases of the skin - No known hypersensitivity to menadion. - No concomitant treatment with Vitamin K or Vitamin K-antagonists - No present psychological, familily, sociological or geographical conditions, which potentially could prevent compliance with the conditions of the protocol and follow-up - No pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): To investigate the possible effect of Vitamin K3-containing lotion of cetuximab induced folliculitis. Secondary end point is to investigate the possible side-effects of Vitamin K3-containing lotion.;Main Objective: To investigate possible effect of vitamin K3-containing lotion on cetuximab-induced folliculitis;Secondary Objective: To investigate possible side-effects when using vitamin K3-containing lotion | — |
Countries
Denmark
Outcome results
None listed