Reducing the frequency and severity of nausea and vomiting in cancer patients
Design
A clinical trial study with a control group with cross-over groups, double-blind, block randomized and phase 3 on 44 cancer patients
Settings and conduct
Ginger and placebo capsules are given to the patient by the nurse in the hospital for 24 hours; The capsule is then taken by the patient. Blinding is done by coded boxes and the wash out period is equivalent to the interval between two cycles of chemotherapy (about one month).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age over 18 years
2. Prescribing chemotherapy regimen based on doxorubicin and platinum compounds by the oncologist
3. Ability to swallow capsules
4. Having chemotherapy experience with nausea and vomiting
5. Presence in the ward for 24 hours to evaluate anti-nausea drugs
6. No history of nausea and vomiting for reasons other than chemotherapy
7. Not receiving anti nausea and vomiting drugs in the last 24 hours
Exclusion criteria:
1. Patients who do not sign the moral consent form.
2. Patients who do not cooperate during treatment for any reason.
3. History of any allergy to ginger
4. Occurrence of nausea before chemotherapy for any reason
5. Having any disease that causes nausea and vomiting, such as hepatitis, gastrointestinal obstruction
6. Taking anticoagulants such as heparin
7. The presence of blood disorders such as platelets less than 10,000 per µl
Intervention groups
The intervention group is the group of patients receiving ginger capsules and the control group is the group of patients receiving placebo capsules; We give the first capsule half an hour before chemotherapy and then every 8 hours for 5 days.
Main outcome variables
The severity and frequency of acute and delayed nausea؛ The severity and frequency of acute and delayed vomiting.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051188N1
Registration date:2021-06-25, 1400/04/04
Registration timing:prospective
Last update:2021-06-25, 1400/04/04
Update count:1
Registration date
2021-06-25, 1400/04/04
Registrant information
Name
Ali Adineh kharrat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4413 7601
Email address
amirali.adn96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2022-01-10, 1400/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ginger in control of nausea and vomiting in cancer patients receiving doxorubicin and platinum based chemotherapy
Public title
The effect of ginger on the severity and frequency of chemotherapy-induced nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Prescribing chemotherapy regimen based on doxorubicin and platinum compounds by the oncologist
Ability to swallow capsules
Having chemotherapy experience with nausea and vomiting
Presence in the ward for 24 hours to evaluate anti-nausea drugs
No history of nausea and vomiting for reasons other than chemotherapy
Not receiving anti-nausea and vomiting drugs in the last 24 hours
Exclusion criteria:
Patients who do not sign the moral consent form.
Patients who do not cooperate during treatment for any reason to continue treatment.
History of any allergy to ginger
Occurrence of nausea before chemotherapy for any reason
Having any disease that causes nausea and vomiting, such as hepatitis, gastrointestinal obstruction
Taking anticoagulants such as heparin
The presence of blood disorders such as platelets less than 10,000 per microliter.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization; Random assignment of participants to a number of fixed capacity blocks in which half of the individuals are assigned to the control group and the other half to the intervention group. The randomization method in this study is to shuffle the cards; In this method, a number of cards selected by the researcher as the first group and the same number of cards for the next groups are considered; Then, by merging the cards together (shuffling the cards), a card is removed and its group is recorded; Coded boxes containing the drug are also used to hide randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind a) patients b) Oncologist and nurse
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences (Biomedical Research Ethics Committee)
Street address
Golestan-Farvardin Blvd.-Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.AJUMS.REC.1400.074
Health conditions studied
1
Description of health condition studied
Chemotherapy induced nausea and vomiting
ICD-10 code
T45.1X5A
ICD-10 code description
Adverse effect of antineoplastic and immunosuppressive drugs
Primary outcomes
1
Description
Frequency of acute and delayed nausea
Timepoint
Frequency of patient nausea up to 24 hours after chemotherapy for acute nausea and frequency of patients nausea p from 24 hours after chemotherapy to 4 days for delayed nausea
Method of measurement
Asking the patient
2
Description
Frequency of acute and delayed vomiting
Timepoint
Frequency of patient vomiting up to 24 hours after chemotherapy for acute vomiting and frequency of patients vomiting from 24 hours after chemotherapy to 4 days for delayed vomiting
Method of measurement
Asking the patient
3
Description
Severity of acute and delayed nausea
Timepoint
Severity of patient nausea up to 24 hours after chemotherapy for acute nausea and severity of patients nausea from 24 hours after chemotherapy to 4 days for delayed nausea
Method of measurement
Stepwise method that is taught to the patient.In this method, the base level is equal to the absence of nausea, steps 1 to 3 is equal to mild nausea, steps 4 to 6 is equal to moderate nausea, steps 7 to 9 is equal to severe nausea and step 10 is the most severe nausea possible.
4
Description
Severity of acute and delayed vomiting
Timepoint
Severity of patient vomiting up to 24 hours after chemotherapy for acute vomiting and severity of patients vomiting from 24 hours after chemotherapy to 4 days for delayed vomiting
Method of measurement
Stepwise method that is taught to the patient.In this method, the base level is equal to the absence of nausea, steps 1 to 3 is equal to mild nausea, steps 4 to 6 is equal to moderate nausea, steps 7 to 9 is equal to severe nausea and step 10 is the most severe nausea possible.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The group receiving the placebo is that the treatment regimen consists of standard antiemetic and vomiting drugs, including 1 ampoule of granistron (Kytril) 3 mg, 1 ampoule of dexamethasone 8 mg, one capsule of 125 mg, and 2 capsules of 80 mg of aprepitant. Placebo capsules (containing starch), so that the patient will receive 1 capsule 30 minutes before taking oral chemotherapy drugs and other capsules every 8 hours for 5 days after chemotherapy.
Category
Treatment - Drugs
2
Description
Intervention group: The intervention group is the drug receiving group whose treatment regimen consists of standard antiemetic and vomiting drugs including 1 ampoule of granistron (kytril) 3 mg and 1 ampoule of dexamethasone 8 mg and one capsule of 125 mg and 2 capsules of 80 mg of aprepitant with 500 mg ginger capsule, so that the patient will receive 1 capsule 30 minutes before taking chemotherapy drugs, orally and other capsules every 8 hours for 5 days after chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghaei 2 hospital
Full name of responsible person
Mohammadjavad Khodayar
Street address
End of Golestan Highway, Shahid Baghaei Square .Baghaei2 Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3375 0410
Fax
Email
shafa.hospital @ajums.ac.ir
Web page address
https://h-baghaei2.ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohamadjavad Khodayar
Street address
Golestan-Farvardin Blvd.-Esfand street
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8378
Email
info@ajums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
MohamadJavad Khodayar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of Toxicology,Faculty of Pharmacy,Ahvaz Jondi Shapor university of medical sciences,Esfand Ave,Farvardin Blvd,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8379
Email
khodayar-mj@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
MohamadJavad Khodayar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Toxicology
Street address
Department of Toxicology,Faculty of Pharmacy,Ahvaz Jondi Shapor university of medical sciences,Esfand Ave,Farvardin Blvd,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8379
Email
khodayar-mj@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ali Adineh-Kharrat
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Ahvaz Jondi Shapor university of medical sciences,Esfand Ave,Farvardin Blvd,Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733184
Phone
+98 61 3373 8379
Email
amirali.adn96@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Research data can be presented if individuals are not identified.
When the data will become available and for how long
It will be available forever for another 8 months when the research and publication of the manuscript is completed.
To whom data/document is available
It will be available to the public.
Under which criteria data/document could be used
The data can be used for further research and studies and by an article extracted from the research.
From where data/document is obtainable
The data will be published in the form of an article and will be available via the following email in case of further details.
jkhodayar@yahoo.com
khodayar-mj@ajums.ac.ir
What processes are involved for a request to access data/document
No special process is required and will be available via email upon request.