Introduction: nausea and vomiting caused by chemotherapy is the most important complication and discomfort for cancer' patients. Nausea and vomiting causes physiologic and electrolyte disorders, Immunity system changes, Nutrition disorders and rupture of esophagus and effect in the quality of life and continuing of patient̉s treatment. Ginger is one vegetable and effective drug for the treatment of nausea and vomiting and doesn’t have any special side effects and some countries use it tor produce antiemetic drugs.
Objective : This study aims to determine the effect of ginger on the severity of chemotherapy induced nausea and vomiting in cancer patients.
Material and Methods: This study is a randomized, cross-over, double – blinded, clinical trial, done on 44 cancer patients undergoing chemotherapy. In the first cycle of the study, Patients randomly assigned by four block random allocation to receive one of the antiemetic regimen (regimen A (routine + 1 gr ginger ) and regimen B(routine +1gr Placebos). In the next cycle of chemotherapy , 28 days after the previous cycle another regimen (A or B ) administrated together with chemotherapy drugs. The severity of the nausea and vomiting were measured in 4h (1,2,3,4 (hours) after second dose and at the end of the 24h after receiving first dose by using of VAS and kortila tools .
Key word: Drug Therapy/ Ginger/ Nausea/ Neoplasms/ Oncologic Nursing/ Vomiting
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706111174N1
Registration date:2010-12-29, 1389/10/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-29, 1389/10/08
Registrant information
Name
Atefeh Ghanbari
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13780509
Email address
at_ghanbari@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Sciences
Expected recruitment start date
2007-08-23, 1386/06/01
Expected recruitment end date
2008-02-20, 1386/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Adding Ginger to Current Treatment on the Intensity of Nausea and Vomitting in Cancer Chemotherapy
Public title
Effects of ginger on Nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18 years old, having experience of chemotherapy along with nausea and vomit, having minimum two chemotherapy periods containing of 50-100 milligram per square meter of sys-platinum, individually or along with other factors of chemotherapy with the similar amount and method of prescription in two chemotherapy cycles without any plan for radiotherapy between two cycles, Remaining in the ward for a period of 24 hours (in order to study of the PRN anti-nausea drugs), Not having nausea and vomit for reasons other than chemotherapy, non-receiving anti-nausea and anti-vomit drugs during the past 24 hours, not receiving treatment with Corticosteroid Drugs during the studied cycles, not-suffering from Hepatitis, obstruction of digestion system, cerebral malignancy or cerebral metastasis and coagulation disorders (plaque less than 100000 per cubic millimeter) based on the registered information in the file and not consuming any anti-coagulation drug. Exclusion criteria: radiothearpy during research, severe nausea and vomiting, not able to eat capsule, stop chemotherapy for any reasons, sever gastroenteritis
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Guilan , Rasht,Guilan University of Medical Sciences
City
Rasht
Postal code
0098
Approval date
2007-07-25, 1386/05/03
Ethics committee reference number
2256
Health conditions studied
1
Description of health condition studied
neoplasm
ICD-10 code
coo-c97
ICD-10 code description
c97
Primary outcomes
1
Description
nausae and vomiting
Timepoint
1, 2, 3, 4, 24 hours
Method of measurement
cheklist
Secondary outcomes
1
Description
nausea and vomiting
Timepoint
28 days after first dose drugs , (change regime A,B) and after that for 1, 2,3,4 and 24 after that , nause and vomit was assessed
Method of measurement
cortilla tool
Intervention groups
1
Description
In the first cycle of the study, patients received one of the antiemetic regimen, regimen A (routine + 1 gr ginger ) or regimen B (routine +1gr Placebos)
Category
Treatment - Drugs
2
Description
In the next cycle of chemotherapy , 28 days after the previous cycle another regimen (A or B ) administrated together with chemotherapy drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan University of Medical Sciences (hematology and cancer research center)
Full name of responsible person
Aefeh Ghanbari
Street address
Namjoo Street , Guilan University of Medical Sciences
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research , Guilan University of Medical Sciences
Full name of responsible person
Dr Abdolrasoul Sobhani
Street address
Namjoo Street , Guilan University of Medical Sciences
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research , Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Rasht , Namjoo Street , Guilan University Of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 1322 2071
Fax
+98 13 1555 0098
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Guialn University of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 1322 2071
Fax
+98 13 1555 0098
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Atefeh Ghanbari
Position
PHD
Other areas of specialty/work
Street address
Rasht, Namjoo Street , Guilan University Of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 1322 2071
Fax
+98 13 1555 0098
Email
at_ghanbari@gums.ac.ir
Web page address
www.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)