A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
18 Years
N/A
Both
Rash Due to Epidermal Growth Factor Receptor Inhibitors
Trial Information
A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
Inclusion Criteria:
- metastatic colon cancer patients
- male or female
- age> 18
- treated EGFRI
Exclusion Criteria:
- prior treatment with EGFRI
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
Outcome Description:
Reduction in numbers of papulo-pustular eruptions in the treatment fields compared to the placebo treated side. Changes in follicular eruptions, dryness/redness of skin estimated by the grading scale developed by the Multinational Association of Supportive Care in Cancer (MASCC) skin toxicity study group 4.0. Patients own experience of efficacy estimated by questionnaire.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Sharon Merims, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hadassah Medcial Organization
Authority:
Israel: Israeli Health Ministry Pharmaceutical Administration
Study ID:
EGFRI-MER-1a-HMO-CTIL
NCT ID:
NCT01763307
Start Date:
January 2013
Completion Date:
December 2014
Related Keywords:
- Rash Due to Epidermal Growth Factor Receptor Inhibitors
- EGFRI
- COLON CANCER
- SKIN TOXICITY
- RECONVAL K1 cream
- Exanthema
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