the effect of topical heparin gel in improving hand and foot syndrome in patients use capecitabine
Design
40 patients are divided into two groups of 20 by simple randomization method, so that the envelopes containing cards A and B will be randomly distributed among the patients. Group A as the intervention group, in addition to standard chemotherapy treatment, will receive heparin sulfate gel 40 mg 4 times a day for 21 days, and group B as the control group will only receive standard treatment and placebo gel. All patients were included in the study before starting cancer treatment with capecitabine. The start of the study coincided with the start of cancer treatment. This study will be conducted in a double-blind manner, so that neither the patient nor the researcher will be aware of the type of intervention.
Settings and conduct
In this clinical trial study, 40 patients who are in the oncology department of Kashani and Hajar Hospital with hand and foot syndrome grade less than 2, age 18 years or older, and in the study by randomization method. They are simply divided into two groups of 20 so that envelopes containing cards A and B will be randomly distributed among the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Newly diagnosed cancer patients for gastrointestinal and head and neck cancer treated with capecitabine
Have the initial symptoms of hand and foot syndrome
Non-entry criteria:
The patient already has a skin or inflammatory disease
Intervention groups
intervention group A, in addition to standard chemotherapy treatment, will receive heparin sulfate gel 40 mg 4 times a day for 21 days, control group B will only receive standard treatment and placebo gel.
Main outcome variables
The amount of erythema, blisters and hyperkeratosis of hand and foot syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230215057423N1
Registration date:2023-05-01, 1402/02/11
Registration timing:registered_while_recruiting
Last update:2023-05-01, 1402/02/11
Update count:0
Registration date
2023-05-01, 1402/02/11
Registrant information
Name
Maede Mirjalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3222 0016
Email address
st_mirjalilim@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Survey the effect of topical heparin gel on the improvement of hand and foot syndrome in cancer patients treated with capecitabine
Public title
The effect of heparin gel in improving hand and foot syndrome in patients treated with capecitabine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Newly diagnosed cancer patients for gastrointestinal tract and head and neck cancer treated with capecitabine and have evidence of early onset of hand-foot syndrome (grade 1 from onset)
Exclusion criteria:
The patient already has a skin or inflammatory disease
The patient's unwillingness to start the trial
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, the permutation block randomization method will be used.
7 blocks with a volume of 6 will be produced by RA software, each block will contain 3 letters A and 3 letters B.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be conducted in a double-blind manner, so that neither the patient nor the researcher is aware of the type of intervention. The placebo gel will be designed with a packaging and appearance completely similar to heparin gel and will be provided to the researcher in the form of coding. The researcher is also unaware of the contents of the packaging. As a result, the data will be collected and provided to the analyst.
In order to randomize, the permutation block randomization method will be used.
7 blocks with a volume of 6 will be produced by RA software, each block will contain 3 letters A and 3 letters B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Parastar street Hajarhaspital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2022-09-14, 1401/06/23
Ethics committee reference number
IR.SKUMS.MED.REC.1401.045
Health conditions studied
1
Description of health condition studied
cancer patient
ICD-10 code
C49.0
ICD-10 code description
Malignant neoplasm of connective and soft tissue of head, face and neck
Primary outcomes
1
Description
Examination of erythema, blisters and hyperkeratosis in hand and foot syndrome
Timepoint
Day zero and day twenty one
Method of measurement
Questionnaire and observation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: Group A as the intervention group, in addition to the standard chemotherapy treatment, will receive heparin sulfate gel 40 mg 4 times a day for 21 days.
Category
Treatment - Drugs
2
Description
Control group: Control group: Group B as a control group, in addition to the standard treatment, receive a placebo that looks like heparin gel.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar and Kashani hospitals in Shahrekord
Full name of responsible person
Ruhollah Masoumi
Street address
parastar street Hajar Haspital
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
masomi51@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ruhollah Masoumi
Street address
Parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
masomi51@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Maede Mirjalili
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
maedemirjalili98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maede Mirjalili
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
maedemirjalili98@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Ruhollah Masoumi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Parastar
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3222 0016
Email
masomi51@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.
When the data will become available and for how long
The access period will start 6 months after the results are published.
To whom data/document is available
Our data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If there are conditions, all our data will be shared except personal information of people. The use of our data will only be allowed for similar research and review of our data by other researchers. All those who work in universities and scientific centers and decide to conduct similar research or check the accuracy of our data can access our data.
From where data/document is obtainable
In order to receive information, all eligible people can collect data by referring to the person in charge of the project. The contact methods are the email address maedemirjalili98@gmail.com or the contact number 00989132736651.
What processes are involved for a request to access data/document
To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.