The goal of this dingle blind clinical trial study is comparison the outcome and complication of adjuvant chemotherapy based on platinum with and without ginger on 90 patients with epithelial ovarian cancer. Into two groups using ran list system. Group A as case and group B as control group each group divided into group 1,2,3 based on stage (1, 2,3,) we give carbolated 5-6 Auc and p ally 175/m2 for each group for 6 cycles and 2 gr ginger/day ( 2 cap 1gr made by Tabriz university of medical sciences for group 1.
We compile the CA125 and scan every 3 months after treatment as primary outcome and free of disease for one year and complicates of treatment between two groups.
Encloses Criteria: women with ovarian cancer who had cytoreductive surgery; Wilting to participate in study
Exclusion criteria: Sensitivity to ginger ; history of previous chemotherapy; history of gynecological cancer; using vit E or omega3; Intolerances to chemotherapy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031510901N4
Registration date:2014-04-09, 1393/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-04-09, 1393/01/20
Registrant information
Name
Parvin Mostafa Gharebaghi
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1553 9161
Email address
gharabagh.p@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor of research, Tabriz University of Medical Sciences
Expected recruitment start date
2014-04-05, 1393/01/16
Expected recruitment end date
2015-08-11, 1394/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the outcomes and side effects of adjuvant chemotherapy with and without ginger in ovarian cancer patients
Public title
Comparing the outcomes and side effects of adjuvant chemotherapy with and without ginger in ovarian cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Encloses Criteria: women with ovarian cancer who had cytoreductive surgery; Wilting to participate in study
Exclusion criteria: Sensitivity to ginger ; history of previous chemotherapy; history of gynecological cancer; using vit E or omega3; Intolerances to chemotherapy
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
vice chancellor of research,Tabriz University of Medical Sciences
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
5138665793
Approval date
2013-12-02, 1392/09/11
Ethics committee reference number
5/4/7614
Health conditions studied
1
Description of health condition studied
ovarian cancer
ICD-10 code
c56
ICD-10 code description
Malignant neoplasm of ovary
Primary outcomes
1
Description
The results of the CT scan of the abdomen and pelvis
Timepoint
Intervals during treatment and after treatment every 3 months for one year
Method of measurement
CT scan of the abdomen and pelvis.
2
Description
CA125 results in the groups receiving platinum and paclitaxel
Timepoint
Intervals during treatment and after treatment every 3 months for one year
Method of measurement
Blood tests
3
Description
Side effects
Timepoint
During treatment
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Karbo platinum dose Taksl Pakly 5-6 AUC and dose of 175 mg per square meter for 6 cycles
Category
Treatment - Drugs
2
Description
Groups: drug Karbv platinum dose 5-6 AUC and Pakly Taksl dose of 175 mg per square meter and ginger (ginger 1 g made at the that Faculty of Pharmacy, Tabriz) at a dose of 2 g daily for 6 cycles administered every two protocol is repeated every 21 days done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Parvin Mostafa Gharabaghi
Street address
Alzahra Hospital, bagh-shomal; Artesh Street South;
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor of research,Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor of research,Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Parvin Mostafa Gharabaghi
Position
Gynecologist, fellow of Women's Oncology / Associate Professor Obstetrics Midwifer
Other areas of specialty/work
Street address
Golgasht Street; Tabriz University of Medical Sciences