Protocol summary
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Study aim
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Reducing the frequency and severity of nausea and vomiting in cancer patients
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Design
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A clinical trial study with a control group with cross-over groups, double-blind, block randomized and phase 3 on 44 cancer patients
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Settings and conduct
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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).
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The severity and frequency of acute and delayed nausea؛ The severity and frequency of acute and delayed vomiting.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210505051188N1
Registration date:
2021-06-25, 1400/04/04
Registration timing:
prospective
Last update:
2021-11-15, 1400/08/24
Update count:
1
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Registration date
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2021-06-25, 1400/04/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-07-11, 1400/04/20
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Expected recruitment end date
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2022-01-10, 1400/10/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of ginger in control of nausea and vomiting in cancer patients receiving doxorubicin and platinum based chemotherapy
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Public title
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The effect of ginger on the severity and frequency of chemotherapy-induced nausea and vomiting
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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.
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Double blind a) patients b) Oncologist and nurse
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Placebo
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Used
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Assignment
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Crossover
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-05-01, 1400/02/11
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Ethics committee reference number
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IR.AJUMS.REC.1400.074
Health conditions studied
1
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Description of health condition studied
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Chemotherapy induced nausea and vomiting
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ICD-10 code
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T45.1X5A
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ICD-10 code description
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Adverse effect of antineoplastic and immunosuppressive drugs
Primary outcomes
1
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Description
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Frequency of acute and delayed nausea
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Timepoint
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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
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Method of measurement
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Asking the patient
2
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Description
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Frequency of acute and delayed vomiting
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Timepoint
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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
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Method of measurement
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Asking the patient
3
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Description
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Severity of acute and delayed nausea
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Timepoint
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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
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Method of measurement
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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
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Description
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Severity of acute and delayed vomiting
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Timepoint
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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
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Research data can be presented if individuals are not identified.
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When the data will become available and for how long
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It will be available forever for another 8 months when the research and publication of the manuscript is completed.
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To whom data/document is available
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It will be available to the public.
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Under which criteria data/document could be used
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The data can be used for further research and studies and by an article extracted from the research.
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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No special process is required and will be available via email upon request.
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Comments
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