Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Recruitment status was Recruiting
The study aims to explore the benefit of topical vitamin K3 lotion for the reactivation/rephosphorylation of EGF-receptor in the skin and the possible reduction in cutaneous side effects of EGFr-inhibition.
Primary aim: The possible reduction of cutaneous side effects: folliculitis, dryness and redness of the skin.
Secondary aim: To explore any possible side effects of topical vitamin K3 lotion.
Methods: 36 patients with metastatic colorectal cancer or metastatic head and neck cancer allocated to treatment with chemotherapy and biweekly cetuximab. Two equally sized areas of at least 10x10 cm on the back or chest of the patient is marked. Patients receive in a double blinded procedure placebo lotion on one side and vitamin K3 lotion on the other side. The treatment may last for a maximum of two months and the patients are followed biweekly with photos, VAS-scores, questionnaires and CTCAE estimations. The patient will be able to take weekly photos at home during the weeks they are not seen at the outpatient clinic. During the treatment all other skin products or antibiotics is allowed and will be carefully registered by the health care professionals in the outpatient clinic.
The patient may enter the trial in two different ways: 18 patients start treatment with study lotions at the time they start treatment with cetuximab. The other 18 patients start treatment with study lotions when folliculitis appears.
Patients are asked for 1.5 mm skin biopsies of both study areas of the skin before start of treatment and after 4 weeks of treatment with placebo lotion and vitamin K3 lotion. These biopsies will be investigated for EGFr, phosphorylated EGFr and other central downstream mechanisms. The biopsy part of the study is optional for the patient.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Placebo-controlled Trial Investigating the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis|
- Potential reduction in skin toxicity by vitamin K3 lotion [ Time Frame: 3 months ] [ Designated as safety issue: No ]Reduction in numbers of papulo-pustular eruptions in the treatment fields. Changes in follicular eruptions, dryness/redness of skin estimated by CTCAE 4.0. Patients own experience of efficacy estimated by questionaire and VAS scale.
- Potential toxicity of vitamin K3 lotion [ Time Frame: 3 months ] [ Designated as safety issue: No ]No systemic or skin toxicity is expected. Therefore all experienced skin changes will be estimated by CTCAE 4.0. Furthermore, broad bloodtest screenings will be done bi-weekly.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Vitamin K3-lotion
A lotion containing 1.5 mM Vitamin K3.
Other: Vitamin K3
Lotion containing 1.5 mM Vitamin K3
No Intervention: B
Standard lotion without Vitamin K3
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094444
|Contact: Per Pfeiffer, Professor, MD, PhD||+45 6541 firstname.lastname@example.org|
|Contact: Jesper Grau Eriksen, MDemail@example.com|
|Odense University Hospital||Recruiting|
|Odense C, Denmark, 5000|
|Contact: Jesper G. Eriksen, MD firstname.lastname@example.org|
|Contact: Per Pfeiffer, professor, MD, PhD +45 6541 2921 email@example.com|
|Principal Investigator: Jesper G. Eriksen, MD|
|Principal Investigator:||Jesper G. Eriksen, MD||Odense University Hospital|