Comparative study of the effect of topical vitamin K with placebo in the treatment of skin rash in patients with metastatic colon cancer treated with Cetuximab
Comparative study of the effect of topical vitamin K with placebo in the treatment of skin rash in patients with metastatic colon cancer treated with cetuximab
Design
A randomized, double-blinded, sham controlled clinical trial with parallel groups, phase 3, on 48 patients.
Settings and conduct
In this randomized double-blind clinical trial study, 48 patients with metastatic colorectal cancer who are candidates for receiving Cetuximab referred to Omid Hospital in Isfahan will be randomly divided into two groups. One group will receive vitamin K cream and the other group will receive a placebo. Then the grade of skin lesions will be evaluated and compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion : Metastatic colorectal cancer patients treating with Cetuximab and skin rash
Not inclusion : Receive any treatment containing vitamin K or any medication that interferes with topical vitamin K intake.
Intervention groups
Intervention group: Patients will use topical vitamin K 0.1% cream twice a day
Control group: Patients will use topical creams, including cream base and without any other additives, twice a day.
Main outcome variables
Reduction of skin lesions' grade
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150304021338N3
Registration date:2021-09-20, 1400/06/29
Registration timing:registered_while_recruiting
Last update:2021-09-20, 1400/06/29
Update count:0
Registration date
2021-09-20, 1400/06/29
Registrant information
Name
Mahnaz Roayaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 7396
Email address
roayaei@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-16, 1400/06/25
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of topical vitamin K with placebo in the treatment of skin rash in patients with metastatic colon cancer treated with Cetuximab
Public title
The effect of topical vitamin K on skin rash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with metastatic colorectal cancer that are candidates for treatment with Cetuximab .
Patients with grade 1 to 4 skin lesions, after using Cetuximab(based on Common Terminology Criteria for Adverse Events4 (CTCAE4))
Be over 18 years old
The patient should not undergo radiotherapy.
Have a desire to participate in the study.
Exclusion criteria:
The patient has skin lesions before receiving cetuximab (including rash, acne, pustules, inflammatory erythema)
Being pregnant or in breastfeeding duration
Previous history of allergies to compounds containing vitamin K
Has a psychiatric disorder that is not able to participate in the study
For other reasons, he is taking drugs that have a drug interaction with topical vitamin K
Be taking medicinal compounds containing vitamin K
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
All patients wish to participate in the study will be randomly divided into two groups A and B, using Random allocation software. Patients will be randomly assigned to intervention or control groups by someone other than the main researcher and statistical analyst, so, the patient, main researcher and statistical analyst will not know that how patients are placed in each group (intervention or control).
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, two drugs, topical Vitamin K cream and placebo, in terms of shape and color, are prepared in the same way and provided to the researcher. They also prescribe them without knowing the type of any of the drugs. Also, the person recording the clinical and basic information of the patients as well as the statistical analyst will not be aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Center of Medical Research - Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2021-07-16, 1400/04/25
Ethics committee reference number
IR.MUI.MED.REC.1400.326
Health conditions studied
1
Description of health condition studied
Skin rash
ICD-10 code
R21
ICD-10 code description
Rash and other nonspecific skin eruption
Primary outcomes
1
Description
Grade of skin lesions, based on Common Terminology Criteria for Adverse Events4 (CTCAE4)
Timepoint
At the beginning of the study and 4 and 8 weeks after using topical vitamin K.
Method of measurement
Based on CTCEA4
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with skin rash has been induced by Cetuximab,will use topical 0.1% vitamin K cream, including a combination of vitamin K1 (Phytonadione) produced by Caspian company and the cream base,twice a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: Patients with skin rash has been induced by Cetuximab, will use topical cream, including cream base And without any other additives, twice a day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Dr. Mahnaz Roayaei
Street address
Omid Hospital, Motahari Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3235 0210
Email
roayaei@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Rezaei
Position
Radiation oncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 0214
Fax
Email
dralirezarezaei1991@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Rezaei
Position
Radiation oncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 0214
Fax
Email
dralirezarezaei1991@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mahmoud Rezaei
Position
Radiation oncology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3235 0214
Fax
Email
dralirezarezaei1991@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available