The effect of Vit D on AMH level and ovarian reserve in 18-40 years old female breast cancer patients who have been treated with chemotherapy between 1397-1398 in Imam Khomeini hospital.
Design
Type of study: phase 3 Randomized clinical trail
In this study 18-40 years old female breast cancer patients will be randomized in 2 groups. age,number of pregnancies, fertility status, menstrual disorders, smoking history, type of surgery and cancer stage will be documented. Before chemotherapy, AMH level will be documented for all patients. One group will be administered with 1000 IU daily calciteriol during and till six month after chemotherapy. The second group will not take vitamin D. The AMH level falls immediately after chemotherapy and will gradually improved during chemotherapy and fully recover after 3-6 month of chemotherapy.The AMH level will be measured before, at the end and 6 month after chemotherapy. all measurements will be in the same lab and with the same manner.
Settings and conduct
Female breast cancer patients between 18-40 years old undergoing neoadjuvant or adjuvant chemotherapy between 1397-1398 in cancer institute of Imam Khomeini hospital will be participated in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Chemotherapy candidate breast cancer patients between 18-40 years-old
Exclusion criteria:
GNRH agonist treatment during or after chemotherapy
Positive history of cytotoxic therapy
Bilateral salpyngo-oophorectomy surgery
EF<50%
Intervention groups
Patients who receive daily vit D from beginning of chemotherapy to 6 months after that considering to randomization.
Main outcome variables
AMH level 6 month after chemotherapy ending.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180718040514N1
Registration date:2019-03-12, 1397/12/21
Registration timing:registered_while_recruiting
Last update:2019-03-12, 1397/12/21
Update count:0
Registration date
2019-03-12, 1397/12/21
Registrant information
Name
Zahra Dastmardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3366 0399
Email address
Zdastmardi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-27, 1397/09/06
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vit D on AMH level and ovarian reserve in female breast cancer patients who have been treated with chemotherapy
Public title
The effect of Vit D on AMH level and ovarian reserve in 18-40 years old female breast cancer patients who have been treated with chemotherapy between 1397-1398 in Imam Khomeini hospital.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chemotherapy candidate Breast cancer patients between 18-40 years- old.
Exclusion criteria:
History of cytotoxic treatment
GNRH agonist treatment during or after chemotherapy
EF<50%
Positive history for BSO(bilateral salpingo-oophorectomy)
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Referred patients are randomized to 2 groups.One receive daily vit D (1000 IU) and other group receive no drug.
Blinding (investigator's opinion)
Single blinded
Blinding description
The analysers are not informed about randomization groups, ,patients and analyser are informed due to lack of placebo in study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional research ethics committee Imam Khomeini hospital
Street address
Tehran , Keshavarz BLVD,Imam Khomeini hospital
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.TUMS.IKHC.REC.1397.237
Health conditions studied
1
Description of health condition studied
Infertility due to breast cancer chemotherapy.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
AMH level before ,immediately after and 6 month after chemotherapy.
Timepoint
Before chemotherapy , immediately after chemotherapy and 6 month after end of chemotherapy.
Method of measurement
ELISA technique in central Imam Khomeini laboratory.
Secondary outcomes
empty
Intervention groups
1
Description
In this study 18-40 years old female breast cancer patients will be randomized in 2 groups. patients with history of cytotoxic therapy or BSO will be excluded.age,number of pregnancies, fertility status,menstrual disorders, smoking history, type of surgery and cancer stage will be documented.Before chemotherapy,AMH level will be documented for all patients. One group will be administered with 1000 IU daily calciteriol during and till six month after chemotherapy.The second group will not take vitamin D.The AMH level falls immediately after chemotherapy and will gradually improved during chemotherapy and fully recover after 3-6 month of chemotherapy.The AMH level will be measured before, at the end and 6 month after chemotherapy. all measurements will be in the same lab and with the same manner.
Category
Treatment - Drugs
2
Description
Control group: the group that receive no drug.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Radiotherapy oncology clinics of institute cancer in Imam Khomeini hospital
Full name of responsible person
Zahra Dastmardi
Street address
Tehran , Keshavarz BLVD, Imam Khomeini hospital ,institute cancer.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
zdastmardi@razi.tums.ac.ir
2
Recruitment center
Name of recruitment center
Haematology oncology clinic institute cancer ImamKhomeini hospital
Full name of responsible person
Dr Zahra Zastmardi
Street address
Tehran , Keshavarz BLVD, Imam Khomeini hospital ,institute cancer.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
zdastmardi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran university of medical science
Street address
Tehran , Keshavarz BLVD, Imam Khomeini hospital ,institute cancer.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
zdastmardi@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Dastmardi
Position
Resident of radiotherapy oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Tehran , Keshavarz BLVD, Imam Khomeini hospital ,institute cancer.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
zahradastmardi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Dastmardi
Position
Resident of radiotherapy oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Tehran , Keshavarz BLVD, Imam Khomeini hospital ,institute cancer.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
zdastmardi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
zahradastmardi
Position
Resident of radiotherapy oncology
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Tehran , Keshavarz BLVD, Imam Khomeini hospital ,institute cancer.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2567
Email
zdastmardi@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Not to diminish patients data.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available