Evaluation of the efficacy of ginger in reduction chemotherapy-induced nausea and vomiting in newly diagnosed breast cancer patients receiving doxorubicin(adriamycin)-based chemotherapy.
Given the wide prevalence of breast cancer in females and chemotherapy- induced nausea and vomiting, a randomized trial designed to evaluate efficacy of ginger on chemotherapy-induced nausea and vomiting. Inclusion criterias include Females with breast cancer, all ages, Prescription of doxorubicin-based chemotherapy and no Previous chemotherapy. Exclusion criterias include uncompleted questionnaires, the receiving of adriamycin for less than three cycles and severe gastrointestinal or coagulation side effects. Targeted populaton include 110 patients that receive chemotherapy in Namazee hospital. Patients randomly assign to intervention group or control group. Both groups receive chemotherapy and standard anti-emetic drugs. Then,intervention group and control group receive Ginger and placebo capsules ,respectively. patients
consume the drugs for three days then complete designed questionnaire.This process is repeated for three cycles. Recruitment time is 6 months, and duration and severity of nausea and vomiting is compared in both groups finally.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050517581N1
Registration date:2015-02-13, 1393/11/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-13, 1393/11/24
Registrant information
Name
Pejman Porouhan
Name of organization / entity
Shiraz University of Medical Sciences (Namazi Hospital)
Country
Iran (Islamic Republic of)
Phone
+98 71 1612 5337
Email address
porouhan@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-08-06, 1393/05/15
Expected recruitment end date
2015-02-04, 1393/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of ginger in reduction chemotherapy-induced nausea and vomiting in newly diagnosed breast cancer patients receiving doxorubicin(adriamycin)-based chemotherapy.
Public title
Evaluation of the efficacy of ginger in reduction chemotherapy-induced nausea and vomiting in newly diagnosed breast cancer patients receiving doxorubicin(adriamycin)-based chemotherapy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
New diagnosed breast cancer ;All ages ;Female ;No previous chemotherapy ;Prescription of doxorubicin-based chemotherapy ;No gastrointestinal obstruction ;No coagulopathy ;Receiving of standard anti-emetic treatment ;Completion of ethic form ;No concurrent hormontherapy or radiotherapy.
Exclusion criteria:
Bleeding ;Development of gastrointestinal obstruction ;Uncompleted questionnaires ;Less than 3 cycle doxorubicin-based chemotherapy
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Shiraz University of Medical Sciences' Ethics Committee
Street address
Shiraz University of Medical Sciences, central building, Zand AVE
City
Shiraz
Postal code
Approval date
2014-08-03, 1393/05/12
Ethics committee reference number
CT-P-9354-5694
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
nausea severity and duration
Timepoint
3-days
Method of measurement
questionnaire
2
Description
vomiting frequency and duration
Timepoint
3-days
Method of measurement
questionnaire
Secondary outcomes
1
Description
Coagulation disorders
Timepoint
3-weeks
Method of measurement
questionnaire
2
Description
gastrointestinal disorders
Timepoint
3-weeks
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: all patients with new breast cancer that assigned to this group randomly, should have Complete Blood Count before any cycle of chemotherapy and all of them receive standard anti-emetic treatment concurrent their chemotherapy (doxorubicin-based) then they receive additional anti-emetic treatment in this manner:
1) capsule ginger 250mg
2) 2 capsule (500 mg) every 12 hours
3) for 3 days in every cycle of chemotherapy
4) for 3 cycles of chemotherapy
Category
Treatment - Drugs
2
Description
Control group: all patients with new breast cancer that assigned to this group randomly, should have Complete Blood Cell before any cycle of chemotherapy and all of them receive standard anti-emetic treatment concurrent their chemotherapy(doxorubicin-based) then they receive additional anti-emetic treatment in this manner:
1)placebo capsule that has similar shape and size with ginger 250mg capsule
2) 2 capsule every 12 hours
3) for 3 days in every cycle of chemotherapy
4) for 3 cycles of chemotherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazee Teaching Hospital
Full name of responsible person
Dr.Pejman Porouhan
Street address
Zand AVE, Namazee SQ
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Ali Poost Foroush Fard
Street address
Vice president for research, Central building, Shiraz University of Medical Sciences, Zand AVE
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Pejman Porouhan
Position
Radiation Oncology Resident
Other areas of specialty/work
Street address
Radiation Oncology Ward, Namazee Hospital
City
Shiraz
Postal code
71937-11351
Phone
+98 71 3612 5367
Fax
Email
porouhan@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mansour Ansari
Position
Assistant Professor, Radiation Oncologist
Other areas of specialty/work
Street address
Radiation Oncology Ward, Namazee Hospital
City
Shiraz
Postal code
71937-11351
Phone
+98 71 3612 5168
Fax
Email
ansarim 1999@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Mohammadian Panah
Position
Associate Professor, Radiation Oncologist
Other areas of specialty/work
Street address
Radiation Oncology Ward, Namazee Hospital
City
Shiraz
Postal code
71937-11351
Phone
+98 71 3612 5168
Fax
Email
mohpanah@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)