A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI
Phase 2
Completed
- Conditions
- Rash Due to Epidermal Growth Factor Receptor Inhibitors
- Interventions
- Drug: RECONVAL CREAMDrug: PLACEBO
- Registration Number
- NCT01763307
- Lead Sponsor
- Hadassah Medical Organization
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- metastatic colon cancer patients
- male or female
- age> 18
- treated EGFRI
Exclusion Criteria
- prior treatment with EGFRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RECONVAL CREAM RECONVAL CREAM half face treated with RECONVAL CREAM PLACEBO PLACEBO half face treated with PLACEBO cream
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method