Comparing the effect of ginger and chamomile on nausea and vomiting caused by chemotherapy in women with breast cancer referred to the Breast cancer research centre, jahad daneshgahi in 2013
The aim of this study was to compare the effect of ginger and chamomile on nausea and vomiting resulting from chemotherapy in (some) cancer patients. The study was a randomized triple blind clinical trial and conducted among 65 patients divided into three groups. Group of subject was randomly sampling selected from the breast cancer patients who receive chemotherapy at the Breast Cancer Research Center at the University of Medical Science one a month and complain of nausea, and the patients were also randomly assigned to two experimental groups and one control group. The experimental group 1 took 1 capsule of ginger besides the routine anti-nausea medication one hour before the chemotherapy, while the experimental group 2 took 1 capsule of Chamomile in the same condition. The control group takes only the routine anti-nausea medication dexamethasone and metoclopramide ampoules, and aprepitant capsule. The duration of experience was 5 days. For recording the frequency and severity of nausea and vomiting each member of three groups filled out the observation forms during this period. Each observation form contains two tables with a 10 cm visual analogue scale. At the end the results of the three groups are calculated and compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013020912404N1
Registration date:2015-03-14, 1393/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-14, 1393/12/23
Registrant information
Name
Fateme Sanaati
Name of organization / entity
Welfare and Rehabilitation Sciences University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0013
Email address
f.sanaati@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice-chancellor, Welfare and Rehabilitation Sciences University of Medical Sciences
Expected recruitment start date
2013-05-06, 1392/02/16
Expected recruitment end date
2014-01-06, 1392/10/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of ginger and chamomile on nausea and vomiting caused by chemotherapy in women with breast cancer referred to the Breast cancer research centre, jahad daneshgahi in 2013
Public title
Effect of ginger and chamomile on nausea and vomiting caused by chemotherapy
Comparing the effect of ginger and chamomile on nausea and vomiting caused by chemotherapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Presence of with breast cancer definite diagnosis by a pathologist؛ age between 20 and 60 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 and chamomile 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
From 20 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Welfare and Rehabilitation Sciences University of Medical Sciences
Street address
Kudakyar Avenue, Student Blvd, Evin, Tehran
City
Tehran
Postal code
1985713834
Approval date
2012-11-28, 1391/09/08
Ethics committee reference number
14126
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
For five days (from one hour before until five days after chemotherapy)
Method of measurement
A 10 centimeter visual analogue scale (VAS)
2
Description
Number of Nausea episodes
Timepoint
For five days (from one hour before until five days after chemotherapy)
Method of measurement
Questionnaire
3
Description
Number of Vomiting episodes
Timepoint
For five days (from one hour before until five days after chemotherapy)
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1 hour for 5 days before and 5 days after chemotherapy, 2 times a day and 500 mg capsules of powdered ginger root in addition to routine antiemetic regimen consisting of dexamethasone and metoclopramide and Aprepitant capsule was consumed
Category
Treatment - Drugs
2
Description
Intervention group 1 hour for 5 days before and 5 days after chemotherapy, 2 times a day and 500 mg capsules of Matricaria Chamomilla extract in addition to routine antiemetic regimen consisting of dexamethasone and metoclopramide and Aprepitant capsule was consumed
Category
Treatment - Drugs
3
Description
Control group, routine antiemetic regimen consisting of dexamethasone and metoclopramide and Aprepitant capsule was consumed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Breast Cancer Research Center, Tehran University of Medical Sciences SID
Full name of responsible person
Dr. Safa Najafi
Street address
martyr St. Vahid Nazari, University Street, Enghelab Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice-chancellor, Welfare and Rehabilitation Sciences University of Medical Sciences
Full name of responsible person
Dr.Hasan Shakeri
Street address
Kudakyar Avenue, Student Blvd, Evin, Tehran
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, Welfare and Rehabilitation Sciences University of Medical Sciences
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
Welfare and Rehabilitation Sciences University of Medical Sciences
Full name of responsible person
Dr.Zahra Kashaninia
Position
Faculty of Nursing
Other areas of specialty/work
Street address
Kudakyar Avenue, Student Blvd, Evin, Tehran
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Fax
Email
kashaninia@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Welfare and Rehabilitation Sciences University of Medical Sciences
Full name of responsible person
Fateme Sanaati
Position
Msc
Other areas of specialty/work
Street address
Kudakyar Avenue, Student Blvd, Evin, Tehran
City
Tehran
Postal code
1985713834
Phone
00
Fax
Email
yaseadine@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Welfare and Rehabilitation Sciences University of Medical Sciences
Full name of responsible person
Fateme Sanaati
Position
Msc
Other areas of specialty/work
Street address
Kudakyar Avenue, Student Blvd, Evin, Tehran
City
Tehran
Postal code
1985713834
Phone
00
Fax
Email
yaseadine@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)