Effect of Ice Sucking on Ginger Extract on Control of Chemo Nausea and vomiting
Design
Clinical trial with a control group, double-blind, randomized on 80 patients using quadruple random blocks
Settings and conduct
The current study is a randomized clinical trial, which will be conducted with the aim of the effect of ginger ice sucking on nausea and vomiting during chemotherapy, and the patients of the oncology department of Ganjovian Hospital (80 patients) will be divided into two control and intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Age older than 20 years old; definitive cancer diagnosis by oncologist; history of receiving at least one course of chemotherapy; history of experiencing nausea and vomiting.
Exit criteria: Patient dissatisfaction; inaccuracy in filling the questionnaires; using anti-emetic drugs; suffering from gastrointestinal diseases.
Intervention groups
The intervention group is cancer patients undergoing chemotherapy who receive the ice ginger. The control group consists of cancer patients undergoing chemotherapy who receive routine treatment
Main outcome variables
Nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170607034381N8
Registration date:2022-10-26, 1401/08/04
Registration timing:prospective
Last update:2022-10-26, 1401/08/04
Update count:0
Registration date
2022-10-26, 1401/08/04
Registrant information
Name
Ferdos Pelarak
Name of organization / entity
Dezful Azad University
Country
Iran (Islamic Republic of)
Phone
+98 916 941 7091
Email address
pelarak.f@dums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-05, 1401/08/14
Expected recruitment end date
2023-02-03, 1401/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Ice Sucking on Ginger Extract on Control of Chemo Nausea
Public title
Effect of ginger ice in nausea and vomiting caused by chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age older than 20 years old
Definitive diagnosis of cancer by an oncologist
History of receiving at least one course of chemotherapy, history of experiencing nausea and vomiting
Exclusion criteria:
Use of antiemetic drugs separate from the routine of other patients
Having a digestive disease
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
80
Cancer patient
Randomization (investigator's opinion)
Randomized
Randomization description
By using the random allocation software, the patients will be randomly assigned to the intervention or placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and researcher do not know which group the people are placed in. By assigning container A and B, the samples do not know whether they are receiving a placebo or the original drug. The statistician will receive the questionnaires anonymously and in the form of A and B and will not know which is the intervention and control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Gachsaran Islamic Azad University
Street address
Islamic Azad University of Gachsaran
City
Gachsaran
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7581863876
Approval date
2021-12-15, 1400/09/24
Ethics committee reference number
IR.IAU.IAUG.REC.1400.002
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
Before intervention and after Chemotherapy
Method of measurement
Rhodes index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: During chemotherapy, 40 pieces of ice containing ginger extract, each piece of ice is 1 cc, will be given to the patient at 1-minute intervals from 5 minutes before the start of chemotherapy to the end of chemotherapy.
Category
Treatment - Drugs
2
Description
Control group: Receive Placebo 40 pieces of ice each piece of ice is 1cc with out ginger extract
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Ganjavian hospital
Full name of responsible person
Fateme Mohtadi
Street address
Gangavian Hospital, Andimesh road to Dezful
City
Dezful
Province
Khouzestan
Postal code
6461643981
Phone
+98 61 4242 2040
Email
bbd@dums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Ershadi
Street address
Islamic Azad University of Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 61 4242 0601
Email
info@iaud.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Ferdos Pelarak
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 916 941 7091
Fax
+98 61 4242 0890
Email
pelarak.f@dums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ferdos Pelarak
Position
instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
+98 916 941 7091
Fax
+98 61 4242 0890
Email
pelarak.f@dums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mohtadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Islamic Azad University of Dezful
City
Dezful
Province
Khouzestan
Postal code
6461645169
Phone
0098 61 424220601
Email
fatememohtadi713@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after unidentifiable individuals
When the data will become available and for how long
12 months after the results are published
To whom data/document is available
Researchers working in scientific and academic institutions
Under which criteria data/document could be used
According to the terms and conditions of Dezful Azad University, the data can be used
From where data/document is obtainable
Fateme Mohtadi fatememohtadi713@gmail.com
What processes are involved for a request to access data/document
Written request and consent of the Executor of the project and colleagues