The effect of ginger and cinnamon in comparison with control group, on chemotherapy induced nausea and vomiting with high emetic drugs in cancer patients
The effect of ginger and cinnamon on chemotherapy induced nausea and vomiting
Design
Randomised, sham controlled, parallel group clinical trial, phase 3 on 144 patients with double blinded outcome assessment. Randomisation was done based on restricted randomization and we will use random allocation rule and numbered drug containers.
Settings and conduct
The target population of this study is cancer patients undergoing chemotherapy in medical centers affiliated to Isfahan University of Medical Sciences.The effect of cinnamon and ginger combination on nausea is assessed with a questionnaire. The drugs are coded by a pharmacotherapist so that all those involved in the research are unaware of the true nature of the capsules and only the analyzer will be informed at the time of analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria are :
Age 18 years and older
Definitive diagnosis of cancer
Receive one-day chemotherapy courses with high emetic risk drugs
Normal hematological and biochemical tests
The following are exclusion criteria:
Receiving concurrent radiotherapy with chemotherapy
Taking therapeutic doses of warfarin, heparin or aspirin
History of hematological disorders
Gastrointestinal cancer
History of allergy to ginger or cinnamon
Taking ginger or cinnamon during the last week
Having other problems causing nausea
Intervention groups
Intervention group is treated with capsules containing Ginger and Cinnamon and the control group takes placebo. The intervention is performed for six days, starting from 3 days before chemotherapy and during this period, in addition to the usual regimens that include Granisetron Hydrochloride and Dexamethasone, the intervention group takes capsules as a supplement every 6 hours, and similarly the control group takes placebo.
Main outcome variables
Nausea severity; Vomiting severity; Nausea frequency; Vomiting frequency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201123049474N1
Registration date:2020-11-27, 1399/09/07
Registration timing:prospective
Last update:2020-11-27, 1399/09/07
Update count:0
Registration date
2020-11-27, 1399/09/07
Registrant information
Name
Mohammad Amin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3781 2884
Email address
dr.mohamad.amin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-20, 1399/09/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ginger and cinnamon in comparison with control group, on chemotherapy induced nausea and vomiting with high emetic drugs in cancer patients
Public title
The effect of ginger and cinnamon on chemotherapy induced nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older
Definitive diagnosis of cancer by oncologist and pathologist
Receive one-day chemotherapy courses with high emetic risk drugs according to the American Society of Clinical Oncology Guidline
Normal hematological and biochemical tests
Exclusion criteria:
Receiving concurrent radiotherapy with chemotherapy
Taking therapeutic doses of warfarin, heparin or aspirin
History of hematological disorders (such as severe thrombocytopenia)
Gastrointestinal cancer
History of allergy to ginger or cinnamon
Taking ginger or cinnamon during the last week
Having other problems causing nausea such as hypertension, liver or kidney failure and digestive problems
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done with a simple random method and creating random values between zero and one in spss software. In order to determine random values to the intervention or control group, less than or equal to 0.5 values are assigned to group A and values greater than 0.5 to group B. The pharmacotherapist then encodes 144 packages (based on the codes obtained in the above randomization method) and determines the list of codes. Inside each package, according to the above method, intervention medicine or placebo will be placed and in order of eligible patients entering the clinic, will be given to the patients and the method of taking the drugs will be explained to the patients by oncologist. Package codes are written on each patient's questionnaire.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drugs and placebo are prepared by pharmacotherapist in similar shapes, colors and weights and are packaged and coded in similar packages in two groups of drugs and placebo so that all people involved in the research are unaware of the main nature of the capsules. After collecting the data, an envelope related to the coding of drug packages and patient information will be provided to the data analyzer.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan medical university
Street address
Ethics committee of Isfahan medical university, Building No. 4, Isfahan medical university, Hezar Jarib Street
City
Isfehan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-24, 1399/09/04
Ethics committee reference number
IR.MUI.MED.REC.1399.753
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Frequency of nausea and vomiting
Timepoint
3 days before chemotherapy to 3 days after and every 12 hours at the same time as the intervention
Method of measurement
The Index of Nausea, Vomiting, and Retching questionnaire
2
Description
Intensity of nausea and vomiting
Timepoint
3 days before chemotherapy to 3 days after and every 12 hours at the same time as the intervention
Method of measurement
The Index of Nausea, Vomiting, and Retching questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Capsules containing 250 mg of Ginger and 250 mg of Cinnamon, which is taken every 6 hours from 3 days before the start of chemotherapy to 3 days after and produced by Amin Pharmaceutical Company
Category
Prevention
2
Description
Control group: Placebo is similar in weight and appearance to the intervention drug produced by Amin Pharmaceutical Company
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Mohammad Amin
Street address
Soffe Blvd, Shahid Keshvari High Way
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir
2
Recruitment center
Name of recruitment center
Omid Hospital
Full name of responsible person
Mohammad Amin
Street address
Motahari Street, Khayyam Expy
City
Isfehan
Province
Isfehan
Postal code
8184917544
Phone
+98 31 3235 0210
Email
Omid@mui.ac.ir
3
Recruitment center
Name of recruitment center
Sheikh Mofid Clinic
Full name of responsible person
Mohammad Amin
Street address
Sheikh Mofid Street
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3663 1677
Email
Mohamad606@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghaiegh Haghjoo Javanmard
Street address
Vice Chancellery for Research and Technology of Isfahan medical university, Building No. 4, Isfahan medical university, Hezar Jarib Street
City
Isfehan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 8138
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
Mohammad Amin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1991
Fax
Email
Dr.mohamad.amin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Amin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1991
Fax
Email
Dr.mohamad.amin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Amin
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Internal medicine department, Alzahra hospital, Soffe Blvd, Shahid Keshvari High Way
City
Isfehan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1991
Fax
Email
Dr.mohamad.amin@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
All collected deidentified IPD
When the data will become available and for how long
6 months after publication
To whom data/document is available
academic institutions
Under which criteria data/document could be used
Any analysis is allowed
From where data/document is obtainable
Email address: Mohammad Amin dr.mohamad.amin@gmail.com
What processes are involved for a request to access data/document
Send the request and the type of data analysis used to the relevant email for review