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IRCT20210505051188N1 IRCT 2021-06-25 Ahvaz University of Medical Sciences The effect of ginger on the severity and frequency of chemotherapy-induced nausea and vomiting Effect of ginger in control of nausea and vomiting in cancer patients receiving doxorubicin and platinum based chemotherapy 2021-07-11 anticipated 44 Complete https://irct.ir/trial/56168 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, 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 description: Double blind a) patients b) Oncologist and nurse. 3 Chemotherapy induced nausea and vomiting. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Research data can be presented if individuals are not identified. When: It will be available forever for another 8 months when the research and publication of the manuscript is completed. To whom: It will be available to the public. Conditions: The data can be used for further research and studies and by an article extracted from the research. Where to obtain: 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 How to obtain: No special process is required and will be available via email upon request. Comments:
public MohamadJavad Khodayar
Department of Toxicology,Faculty of Pharmacy,Ahvaz Jondi Shapor university of medical sciences,Esfand Ave,Farvardin Blvd,Golestan
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8379 khodayar-mj@ajums.ac.ir Ahvaz University of Medical Sciences scientific MohamadJavad Khodayar
Department of Toxicology,Faculty of Pharmacy,Ahvaz Jondi Shapor university of medical sciences,Esfand Ave,Farvardin Blvd,Golestan
Ahvaz Iran (Islamic Republic of) 6135733184 +98 61 3373 8379 khodayar-mj@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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. T45.1X5A Adverse effect of antineoplastic and immunosuppressive drugs Treatment - Drugs Treatment - Drugs 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. 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 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. 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. 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. 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. Ahvaz University of Medical Sciences Approved 2021-05-01 Ahvaz Jundishapur University of Medical Sciences (Biomedical Research Ethics Committee) Ahvaz Jondi Shapor university of medical sciences,Esfand Ave,Farvardin Blvd,Golestan Ahvaz Khouzestan Iran (Islamic Republic of)