A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI

Hadassah Medical Organization18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rash Due to Epidermal Growth Factor Receptor Inhibitors

Interventions

RECONVAL CREAMDRUG

PLACEBODRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * metastatic colon cancer patients * male or female * age\> 18 * treated EGFRI Exclusion Criteria: * prior treatment with EGFRI

Outcomes

Primary Outcomes

Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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