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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01763307
First received: December 24, 2012
Last updated: January 7, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Rash Due to Epidermal Growth Factor Receptor Inhibitors
Drug: RECONVAL CREAM
Drug: PLACEBO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RECONVAL CREAM
half face treated with RECONVAL CREAM
Drug: RECONVAL CREAM
Placebo Comparator: PLACEBO
half face treated with PLACEBO cream
Drug: PLACEBO

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • metastatic colon cancer patients
  • male or female
  • age> 18
  • treated EGFRI

Exclusion Criteria:

  • prior treatment with EGFRI
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763307

Contacts
Contact: Hadas` Lemberg, PHD LLB +972 2 6776095 lhadas@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Sharon Merims, MD Hadassah Medcial Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01763307     History of Changes
Other Study ID Numbers: EGFRI-MER-1a-HMO-CTIL
Study First Received: December 24, 2012
Last Updated: January 7, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
EGFRI
COLON CANCER
SKIN TOXICITY
RECONVAL K1 cream

Additional relevant MeSH terms:
Exanthema
Skin Diseases

ClinicalTrials.gov processed this record on July 10, 2014