objectives:Metformin has been recently reported to be beneficial as an adjunctive therapy in cancer recurrence in patients receiving chemotherapy. In this study, efficacy of metformin in combination with chemotherapy will be investigated in patients with ovarian cancer.
design: randomized clinical trial
setting and conduct:70 women with histopathologic diagnosis of epithelial ovarian carcinoma undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy in shahid faghihi hospital(shiraz)march 2011 to march 2015 were randomized into case and control group;30 patients receiving standard chemotherapy plus metformin as the case group and 40 patients receiving only standard chemotherapy as the control group.
including criteria:women with histopathologic diagnosis of epithelial ovarian carcinoma undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy in shahid faghihi hospital(shiraz)march 2011 to march 2015 were included.
those with the following criteria were excluded from the study:
diabetic patients; patients with liver or gastrointestinal disorders or renal failure; patients unable to tolerate metformin; patients who received neoadjuvant chemotherapy before cytoreductive surgery; patients whose ovarian cancer is secondary to other cancers
intervention:; the study group received 500 mg metformin three times a day in addition to standard chemotherapy sessions after surgical resection of the primary ovarian cancer. The control group received only the standard chemotherapeutic agents after surgery.
main outcome measures:
1-monthly serum ca125 level
2-monthly pelvic ultrasound
3-monthly pelvic examination
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022726788N1
Registration date:2016-07-31, 1395/05/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-31, 1395/05/10
Registrant information
Name
Shohreh Roozmeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7251
Email address
shohreh.roozmeh@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-02-28, 1389/12/09
Expected recruitment end date
2013-02-28, 1391/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
combination of metformin and standard chemotherapy decreases recurrence rate of epithelial ovarian cancers
Public title
chemotherapy plus metformin reduces recurrence of ovarian cancer
Purpose
Treatment
Inclusion/Exclusion criteria
all women with histopathologic diagnosis of epithelial ovarian carcinoma undergone total abdominal hysterectomy and bilateral salpingo-oophorectomy in shahid faghihi hospital(shiraz)march 2011 to march 2015 were included.
those with the following criteria were excluded from the study:
diabetic patients; patients with liver or gastrointestinal disorders or renal failure; patients unable to tolerate metformin; patients who received neoadjuvant chemotherapy before cytoreductive surgery; patients whose ovarian cancer is secondary to other cancers
Age
From 30 years old to 80 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Medical ethics committee of Shiraz University of Medical
Street address
Zand st
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
153/11/41/9p
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
2 year recurrence rate
Timepoint
2 years
Method of measurement
Visit
Secondary outcomes
1
Description
Disease free survival
Timepoint
2-4 years
Method of measurement
Visit
Intervention groups
1
Description
In the study group, a 500mg daily dose of metformin was started (gradually increasing to 1500 mg daily divided three times a day within a week) in addition to standard carboplatin-paclitaxel regimen
Category
Treatment - Drugs
2
Description
The control group receives standard chemotherapy regimen.in stage 1 or 2 of cancer they recieved 3-6 courses of carboplatin-paclitaxel regimen chemotherapy while patients in stage 3 or 4 recieved 6-9 courses .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
OB/GYN department, Shahid Faghihi hospital,Shiraz
Full name of responsible person
Shohreh Roozmeh
Street address
OB/GYN department , Shahid Faghihi hospital, Zand ST, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Shiraz University of Medical Sciences
Full name of responsible person
Zohreh Tavana
Street address
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand street
City
Shiraz
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, 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
Shohreh Roozmeh
Position
MD
Other areas of specialty/work
Street address
Department of OB/GYN, Shahid Faghihi hospital, Zand ST, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3235 1087
Fax
Email
shohreh.roozmeh@yums.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
Shohreh Roozmeh
Position
Gynecologist
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Shahid Faghihi hospital , zand ST, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3235 1087
Fax
Email
shohreh.roozmeh@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shohreh Roozmeh
Position
Gynecologist
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Shahid Faghighi Hodpital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 1087
Fax
Email
shohreh.roozmeh@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)