Investigation of the Effect of Vitamin K3-lotion for the Treatment of Cetuximab Induced Folliculitis
NCT ID: NCT01094444
Last Updated: 2020-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2010-05-31
2014-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vitamin K3-lotion
A lotion containing 1.5 mM Vitamin K3.
Vitamin K3
Lotion containing 1.5 mM Vitamin K3
B
Standard lotion without Vitamin K3
No interventions assigned to this group
Interventions
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Vitamin K3
Lotion containing 1.5 mM Vitamin K3
Eligibility Criteria
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Inclusion Criteria
* Age at least 18 years
* Informed written consent according to local and national legislation
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Per Pfeiffer
OTHER
Responsible Party
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Per Pfeiffer
Professor
Principal Investigators
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Jesper G. Eriksen, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense C, , Denmark
Countries
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References
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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.
Other Identifiers
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09.15
Identifier Type: -
Identifier Source: org_study_id