Clinical trial NCT01094444: Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Official title: Placebo-controlled Trial Investigating the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Folliculitis
Keywords: Vitamin K3 lotion
Cetuximab induced folliculitis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Planned or ongoing treatment with cetuximab
* Age at least 18 years
* Informed written consent according to local and national legislation

Exclusion Criteria:

* Known disease that can influence either treatment, evaluation and the outcome of the current disease and treatment, including chronic dermatology
* Known hypersensitivity to menadion
* Concomitant treatment with Vitamin K or Vitamin K-antagonists
* Known psychological, family, sociological or geographic conditions which potentially can influence planned study treatment or follow-up

Primary outcomes:
measure: Potential reduction in skin toxicity by vitamin K3 lotion
timeFrame: 3 months
Secondary outcomes:
measure: Potential toxicity of vitamin K3 lotion
timeFrame: 3 months
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Jesper G. Eriksen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksen JG, Kaalund I, Clemmensen O, Overgaard J, Pfeiffer P. Placebo-controlled phase II study of vitamin K3 cream for the treatment of cetuximab-induced rash. Support Care Cancer. 2017 Jul;25(7):2179-2185. doi: 10.1007/s00520-017-3623-x. Epub 2017 Feb 15.