The aim of this study is to determine the antiemetic effect of ginger on nausea and vomiting induced by chemotherapy drugs. This study is a phase II randomized, double-blind, placebo-controlled trial that will be conducted in cancer institute of Imam khomeini hospital, Tehran, Iran. 80 women with breast cancer (including 40 patients in the ginger and 40 in the placebo group), receiving chemotherapy will receive 1 gram of ginger root powder or placebo (lactose) orally/day (250mg capsule every 6h) for six days, starting three days before and ending three days after chemotherapy session. During this period, severity and number of nausea and vomiting episodes will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138811203319N1
Registration date:2009-07-23, 1388/05/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-07-23, 1388/05/01
Registrant information
Name
Seyyed Meisam Ebrahimi
Name of organization / entity
Nursing & Midwifery College, Tehran University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
66927171009821
Email address
sm_ebrahimi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2009-12-21, 1388/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ginger (zingiber officinale) on the nausea and vomiting induced by cancer chemotherapy.
Public title
Effect of ginger on chemotherapy induced nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of with breast cancer definite diagnosis by a pathologist, age more than 18 years, receiving chemotherapy, having at least one chemotherapy session before, having history of nausea and vomiting after chemotherapy, having one-day chemotherapy sessions
Exclusion criteria: multi-days chemotherapy sessions, simultaneous radiotherapy inducing nausea and vomiting such as whole body or upper abdomen RT, consuming warfarin and heparin for treatment, consuming ASA more than 80mg, receiving heparin (except for iv-lines), history of blood discrasies, history of severe thrombocytopenia, allergy to ginger or consuming during the past week, gastro-intestinal cancers, having other nausea and vomiting inducing factors except chemotherapy such as CNS tumors, HTN, renal failure or hepatic disorders, gastrointestinal problems like gastric or peptic ulcers, forgetting the use of capsules 3 consecutive times or more
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences and Health Services
Street address
6th Floor, Central Organization, Next to Qods St., Keshavarz Boulevard
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
909/130/ص/88
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 severity
Timepoint
Data are recorded daily for six days (starting 3days before chemotherapy session).
Method of measurement
A 10 centimeter visual analogue scale (VAS)
2
Description
Number of Nausea episodes
Timepoint
Data are recorded daily for six days (starting 3days before chemotherapy session).
Method of measurement
Questionnaire
3
Description
Number of Vomiting episodes
Timepoint
Data are recorded daily for six days (starting from 3 days before chemotherapy session)
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Heart burn
Timepoint
Data are recorded daily for six days (starting 3 days before chemotherapy session).
Method of measurement
Questionnaire
Intervention groups
1
Description
Capsules of 250mg lactose are used qid (1g/day) for six days. placebo capsules are equal to ginger capsuls according to color, odor, taste, shape and dosage.
Category
Placebo
2
Description
Capsules of 250mg ginger powder are used qid (1g/day) for six days. Ginger capsules are equal to placebo capsuls according to color, odor, taste, shape and dosage.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cancer Institute
Full name of responsible person
Dr. Sanambar Sadighi
Street address
Cancer Institute Central 2, Dr. Gharib St,
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-chancellor, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Fotohi
Street address
6th Floor, Central Organization, Next to Qods St., Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice-chancellor, Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery College, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Dr. Zohreh parsa yekta
Position
Associate professor
Other areas of specialty/work
Street address
3rd Floor, Nursing Department, Nursing and Midwifery College, East Nosrat St., Tohid Sq.
City
Tehran
Postal code
Phone
00982166927171
Fax
Email
zparsa@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery College, Tehran University of Medical Sciences and Health Services
Full name of responsible person
Seyyed Meisam Ebrahimi
Position
Msc
Other areas of specialty/work
Street address
3rd Floor, Nursing Department, Nursing and Midwifery College, East Nosrat St., Tohid Sq.
City
Tehran
Postal code
Phone
+98 24 2522 6900
Fax
Email
sm_ebrahimi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery College, Tehran University of Medical Science and Health Services
Full name of responsible person
Seyyed Meisam Ebrahimi
Position
Msc
Other areas of specialty/work
Street address
3rd Floor, Nursing Department, Nursing and Midwifery College, East Nosrat St., Tohid Sq.
City
Tehran
Postal code
Phone
Fax
Email
sm_ebrahimi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)