Rash Due to Epidermal Growth Factor Receptor Inhibitors
Conditions
Keywords
EGFRI, COLON CANCER, SKIN TOXICITY, RECONVAL K1 cream
Brief summary
Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients. This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.
Interventions
DRUGRECONVAL CREAM
DRUGPLACEBO
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* metastatic colon cancer patients * male or female * age\> 18 * treated EGFRI
Exclusion criteria
* prior treatment with EGFRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI | 12 weeks | 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 results
None listed