The effect of captopril added to standard chemotherapy regimen containing capecitabine in the prevention of hand and foot syndrome in patients with colorectal
Determining the effect of Captopril in the prevention and treatment of hand and foot syndrome in patients with colorectal cancer undergoing chemotherapy with capsitabin
Design
In this study, randomized double-blind clinical trial of phase three with the control group, 66 patients undergoing chemotherapy with Capesitabin will distributed in two groups. In the first group of Captopril and in the second group of placebo were prescribed and the incidence of hand and foot syndrome in both groups was determined and compared.
Settings and conduct
This study is a double-blind randomized clinical trial conducted in 2021 in Seyed Al-Shohada Hospital in Isfahan. This study is a double-blind study and the patient and the researcher are unaware of the type of drug received.
Participants/Inclusion and exclusion criteria
In this study, patients with colorectal cancer undergoing chemotherapy with capsaicin. Patients taking drugs affecting foot syndrome as well as patients with kidney and liver disease and hypertension sensitive to captopressil are not included in the study.
Intervention groups
Patients in the intervention group were prescribed two 25 mg captopril tablets daily (manufactured by Elixir Pharmacy under the brand name Captopril Elixir) and in the control group, two placebo tablets daily, which have a similar appearance to 25 mg captopril, were prescribed one week before. The start of chemotherapy was prescribed until the end of the third period.
Main outcome variables
Hand and foot syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012782N50
Registration date:2020-12-02, 1399/09/12
Registration timing:prospective
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
Ali Mehrabi kushki
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1510
Email address
mehrabi@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of captopril added to standard chemotherapy regimen containing capecitabine in the prevention of hand and foot syndrome in patients with colorectal
Public title
Evaluation of the effect of captopril in the prevention of hand and foot syndrome and in patients with colon cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Colorectal cancer candidate for chemotherapy with capsaicin
Patient consent to participate in the study
Exclusion criteria:
Taking drugs that affect the incidence of hand and foot syndrome, including taking second-generation antipsychotics
Suffering from metabolic diseases including diabetes and kidney disease
Having high blood pressure
Sensitivity to Captopril
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients between the intervention and control groups is done using random allocation software. In this software, the total sample size and number of nodes are entered into the software. The output of Shalam software is a list that randomly distributes patients in groups 1 and 2. Patients are divided into two groups according to the time of referral according to the list of the mentioned group until the end of sampling.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed in double blinds and patients and researchers are unaware of the type of drug received. Drugs are prepared in coded form in similar packages and are provided to the executor for prescription to patients. Outcome assessment is also done by someone who is not in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib hospital
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.MUI. MED.REC.1397.025
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C18-19
ICD-10 code description
Malignant neoplasm of colon and rectum
Primary outcomes
1
Description
Hand and foot syndrome
Timepoint
Every 3 weeks
Method of measurement
Physical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients receiving 25 mg of captopril tablets daily for six weeks
Category
Prevention
2
Description
Control group: A placebo recipient who looks similar to Captopril and contains flour once a day for 6 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Seyedoshohada Hospital
Full name of responsible person
Noushin Nazeminejad
Street address
Seyedoshohada hospital, Khayam street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
nooshin.nazemi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Research Deputy, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 3070
Email
sh_haghjoo@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
Mahnaz Roayaei
Position
Assistant profesor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Khayyam street, Seyedoshohada hospital
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3668 5555
Email
mahnaz.roayaei5@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nadia Najafizadeh
Position
Assistant profesor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Khayyam street, Seyedoshohada hospital
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 5555
Email
n_najafizadeh@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
School of Medicine, Isfahan University of Medical Sciences, Hezarjerib street
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3356 3466
Email
al.mehrabi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The plan belongs to a government agency and cannot be published.