Objective: investigation the success rate of vitamin D and chemotherapy compared with chemotherapy in the treatment of chemotherapy
Design: Since vitamin D and its anabolic steroids inhibit the growth of ovarian cancer cells and stimulate apoptosis in animal models and ovarian cancer cell culture media, we decided that investigate of the effects of vitamin D in the treatment of chemotherapy.
Setting and conduct: This study is a prospective clinical trial, double blind and randomization, with control group . The study will be performed in the Hospitals of Mashhad University of Medical Sciences on women With advanced stages of epithelial ovarian cancer, the stages that are candidates for post-surgical chemotherapy, that have not any history diseases such as Liver, kidney and etc. will be done. The randomization is done by using closed envelopes.
Inclusion criteria: age over 20 years; Patients with advanced stages of epithelial ovarian cancer, candidate for postoperative chemotherapy
Exclusion criteria: history diseases such as Liver, kidney,…,
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017101833680N4
Registration date:2017-10-27, 1396/08/05
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-10-27, 1396/08/05
Registrant information
Name
Farideh Golhasani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2631
Email address
golhasanif1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2018-03-20, 1396/12/29
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vitamin D and chemotherapy compared with chemotherapy in the treatment of chemotherapy after ovarian cancer surgery
Public title
The effect of vitamin D and chemotherapy compared with chemotherapy in the treatment of chemotherapy after ovarian cancer surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age over 20 years; Patients with advanced stages of epithelial ovarian cancer, candidate for postoperative chemotherapy
Exclusion criteria: history diseases such as Liver, kidney and etc.
Age
From 20 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Ethics committee of Mashhad University of Medical sciences
Street address
Mashhad University of Medical Sciences, International Offic Administration Center(Qoreishi Building), Daneshgah St.
City
Mashhad
Postal code
91388-13944
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUMS.FM.REC.1395.247
Health conditions studied
1
Description of health condition studied
ovarian cancer
ICD-10 code
C51-C58
ICD-10 code description
Malignant neoplasms of female genital organs
Primary outcomes
1
Description
Liver toxicity
Timepoint
After intervention
Method of measurement
Score
2
Description
locopeni
Timepoint
After intervention
Method of measurement
Score
3
Description
Tumor examination
Timepoint
Before and after intervention
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group, a chemotherapy-like control group, is given 50000 unit of vitamin D orally 1 to 8 weeks.
Category
Treatment - Drugs
2
Description
The control group, the usual chemotherapy, includes the carboplatin and paclitaxel regimen every 3 weeks, once every 3 cycles with placebo will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Qaem Educational, Research and Treatment Center
Full name of responsible person
Dr. Setareh Kasaeian
Street address
Department of Obstetrics and Gynecology, Ghaem Hospital, Ahmadabad .st.
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Mahyar Mirheidari
Street address
Daneshgah St, Ghoreishi Department
City
Mashhad
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, Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Setsre Kasaeian
Position
Resident, Colleague
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2608
Fax
Email
Setare.kasaeian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Malideh Hsanzadeh Mofrad
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Imam Reza Hospital, Taghiabad Square.
City
Mashhad
Postal code
91766-99199
Phone
+98 51338400000
Fax
Email
hasanzademofradm@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farideh Golhasani
Position
Master
Other areas of specialty/work
Street address
Woman Health Research Center, Imam Reza Hospital, Taghiabad Square.
City
Mashhad
Postal code
9137913316
Phone
+98 51 3802 2078
Fax
Email
golhasanif1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)