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Evaluation of the Protective Effect of Metformin against the Tamoxifen Induced Changes on Endometrium and Ovaries in Women with Breast Cancer

Protocol summary

Study aim
Determine the Protective Effect of Metformin against the Tamoxifen on endometrium and ovary in women with breast cancer
Design
A randomized clinical trial with the parallel groups, with control group, double-blind, phase 3 with 100 patients. The block randomization method will be designed by using "www.sealedenvelope.com"
Settings and conduct
This study will be conducted at Arash Women's hospital on patients taking tamoxifen due to breast cancer. Participants will be randomly assigned into two groups; group 1 (metformin) and group 2 (placebo). Once before and then once six months after the start of the intervention, the endometrial thickness and number of the ovarian cysts will be assessed by ultrasound.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adjutant treatment of breast cancer with tamoxifen; Normal pelvic exam, Performance state 0-2. Exclusion criteria: Systemic diseases; use of systemic hormone therapy 6 months ago; alcohol consumption; diabetes; advanced breast cancer; having any cancer or malignancy except for breast cancer during the last three years; atypical hypoplasia or endometrial cancer; abnormal ovarian cysts with the possibility of malignancy on ultrasound; contraindications to the use of metformin (eg: allergy to biguanides, acidosis, heart disease; gastroparesis, liver disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairment)
Intervention groups
Intervention groups: Metformin 500 mg,oral tablets, three times a day for 6 months Control group: participants in the control group will take three placebo tablets daily for 6 months
Main outcome variables
Ovarian cyst

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140820018866N9
Registration date: 2021-03-18, 1399/12/28
Registration timing: prospective

Last update: 2021-03-18, 1399/12/28
Update count: 0
Registration date
2021-03-18, 1399/12/28
Registrant information
Name
Afsaneh Tehranian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
afsanehtehranian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Protective Effect of Metformin against the Tamoxifen Induced Changes on Endometrium and Ovaries in Women with Breast Cancer
Public title
Evaluation of the Protective Effect of Metformin against the Tamoxifen Induced Changes on Endometrium and Ovaries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adjutant treatment of breast cancer with tamoxifen Normal pelvic exam Performance state 0-2
Exclusion criteria:
Serious diseases, heart or endocrine or other systemic diseases Use of systemic hormone therapy during past 6 months Alcohol consumption Diabetes Advanced breast cancer Having any cancer or malignancy other than breast cancer during the last three years Atypical hypoplasia or endometrial cancer abnormal ovarian cysts with the possibility of malignancy on ultrasound Contraindications for using metformin (eg: allergy to biguanides, acidosis, heart disease, alcohol consumption, gastroparesis, liver disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairment) Unbearable and dangerous side effects of metformin (such as: abdominal pain, chest pain, chills, cholestasis, severe diarrhea, dizziness, increased liver enzymes, severe headache, hepatitis, hypoglycemia, megaloblastic anemia, myalgia, palpitations, Skin rash and rash, vomiting)
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The considered sample size is 100, with 50 participants in each group. The block randomization method will be designed by using "www.sealedenvelope.com". The size of blocks considered is 4. The random allocation list for patients will be solely available to the epidemiologist. To hide the random allocation process, 100 card sequences of treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. A 10-digit random code will be written on each packet as the patient's identification number. When the physician announces the eligibility of a patient, the methodologist will provide the envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The physician, patient, and outcome assessor are unaware of the type of intervention
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.427

Health conditions studied

1

Description of health condition studied
ovarian cysts
ICD-10 code
N83.2
ICD-10 code description
Other and unspecified ovarian cysts

Primary outcomes

1

Description
Endometrial thickness
Timepoint
Before and after treatment
Method of measurement
Vaginal ultrasoun

2

Description
Number and characteristic of ovarian cyst
Timepoint
Before and after treatment
Method of measurement
Vaginal ultrasound

Secondary outcomes

1

Description
Changes in liver enzymes
Timepoint
Before and after treatment
Method of measurement
laboratory test

2

Description
Chenges in weight
Timepoint
Before and after treatment
Method of measurement
Scales

3

Description
changes in weight
Timepoint
Before and after treatment
Method of measurement
Laboratory test

Intervention groups

1

Description
Intervention group: Metformin 500 mg ,oral tablets, three times a day for 6 months.
Category
Treatment - Drugs

2

Description
Control group: participants in the control group will take three placebo tablets daily for 6 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr Afsaneh Tehranian
Street address
No. 162 Aَlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
afsanehtehranian@yahoo.com
Web page address
http://arash.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeiyan
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8838 8988
Email
resdeputy@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
Afsaneh Tehranian
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Sciences, Qhods st., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3293
Email
afsanehtehranian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afsaneh Tehranian
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tehran University of Medical Sciences, Qhods st., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3293
Email
afsanehtehranian@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afsaneh Tehranian
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Qhods st., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3293
Email
afsanehtehranian@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
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