NCT01763307

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2013

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 29, 2024

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

December 24, 2012

Last Update Submit

February 28, 2024

Conditions

Rash Due to Epidermal Growth Factor Receptor Inhibitors

Keywords

EGFRICOLON CANCERSKIN TOXICITYRECONVAL K1 cream

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

RECONVAL CREAM

EXPERIMENTAL

half face treated with RECONVAL CREAM

Drug: RECONVAL CREAM

PLACEBO

PLACEBO COMPARATOR

half face treated with PLACEBO cream

Drug: PLACEBO

Interventions

RECONVAL CREAMDRUG
RECONVAL CREAM
PLACEBODRUG
PLACEBO

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • prior treatment with EGFRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Sharon Merims, MD

    Hadassah Medcial Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2012

First Posted

January 8, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

December 1, 2018

Last Updated

February 29, 2024

Record last verified: 2017-08