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Evaluation of the Effect of Metformin on Breast Fibrocystic Changes

Protocol summary

Study aim
Determination of the effect of metformin on breast fibrocystic changes
Design
A concealed, randomized, blinded, placebo-controlled clinical trial with a parallel group design of 148patients
Settings and conduct
This study will be conducted on eligible participants attending Arash Hospital and would give consent to participate in the study. Before the randomization, random blood glucose, liver and kidney function, and CBC tests will be checked. Participants will be randomly divided into intervention and control groups. None of the research team members (except epidemiologist) and participants will be informed about the random allocation process. Demographic characteristics, dietary intake, physical activity level, and anthropometric indexes will be measured and recorded by a trained interviewer. FCC related symptoms such as pain, nodularity, and tenderness of the breast will be assessed by the surgeon. The radiologist will complete the FCC ultrasound scoring table. Participants will be monitored every two weeks during the intervention period and they will be advised to keep their routine diet during the study and inform the researcher if they need to use any other medications, supplements or other therapies.
Participants/Inclusion and exclusion criteria
Women of reproductive age with breast fibrocystic changes will be included and cases with menopause, obesity, use of hormonal or metabolic drugs, breast cancer, hormonal disorders, metabolic and internal diseases, pregnancy or breastfeeding, and having contraindications, or a history of unwanted and intolerable side effects for metformin drug, will not be included
Intervention groups
Intervention: Includes 74people who will take metformin 500 mg tablets twice a day for 6 months Control: Includes 74people who will take placebo tablets twice a day for 6 months
Main outcome variables
Mastalgia; Nodularity; Tenderness; ultrasonographic findings

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100706004329N6
Registration date: 2018-10-06, 1397/07/14
Registration timing: registered_while_recruiting

Last update: 2018-10-06, 1397/07/14
Update count: 0
Registration date
2018-10-06, 1397/07/14
Registrant information
Name
Sadaf Alipour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982177888751 - 00982177883195
Email address
salipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Metformin on Breast Fibrocystic Changes
Public title
Metformin in Fibrocystic Changes of Breast
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of fertility FCC diagnosis based on history, examination and ultrasound.
Exclusion criteria:
Menopause Body mass index greater than 29.9 kg / m2 Use of hormonal medications (such as estrogen, progesterone, GnRH agonist, GnRH antagonist, clomiphene, tamoxifen, letrozole, danazol, contraceptive pills, progesterone IUDs, DHEA) and drugs that affect metabolic status, such as weight, glucose, and lipid-lowering agents During the study or three months before the study began Hormonal disorders and metabolic diseases such as hypo or hyperthyroidism, metabolic syndrome, diabetes, severe hyperlipidemia, galactorrhea Proven or suspected pregnancy and lactation during the intervention Other medical conditions, such as cardiovascular disease, epilepsy, renal or hepatic disorders Contraindications for metformin use (such as hypersensitivity to biguanides, acidemia, heart disease, alcohol consumption, gastroparesis, hepatic disease, hyperthyroidism or hypothyroidism, severe iron deficiency anemia, renal impairments) History of unwanted and intolerable side effects of metformin (such as abdominal pain, chest pain, chills, cholestasis, diarrhea, dizziness, increased liver enzymes, severe headache, hepatitis, hypoglycemia, megaloblastic anemia, myalgia, nausea, Palpitations, rash, rash, vomiting)
Age
From 15 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
Randomization description
We will use the blocked randomization method by using a web-based random number generator at www.sealedenvelope.com. Blocks size are considered to be 6.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The random allocation list will be provided exclusively to the epidemiologist. To conceal the random allocation process, 148 drugs envelopes with the same shape will be numbered with a 10-digit random code, which is the drug identification number. The code recognition key will be only available to the methodologist. All envelopes will be placed in a box in the order and on the basis of the random allocation list and will be available to the corresponding member. When the breast surgeon declares the patient's eligibility, the methodologist will provide the doctor with the envelope. The treatment plan will be selected based on the type of treatment mentioned in the envelope. None of the patients should be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is a third party who is unaware of the random allocation process and the type of treatment. The statistician who will analyze the data will be unaware of the type of intervention performed.
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 Sciences
Street address
Qods St, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-08-18, 1397/05/27
Ethics committee reference number
IR.TUMS.VCR.REC.1397.358

Health conditions studied

1

Description of health condition studied
Fibrocystic Changes of the braest
ICD-10 code
N64.9
ICD-10 code description
Disorder of breast, unspecified

Primary outcomes

1

Description
Mastalgia
Timepoint
At the beginning of the study (before the intervention), three months and six months after the intervention began
Method of measurement
Questionnaire (Visual Analog Scale)

2

Description
Breast nodularity
Timepoint
At the beginning of the study (before the intervention), three months and six months after the intervention began
Method of measurement
Clinical examinations by the surgeon and registration in a standard checklist designed by the researchers

3

Description
Breast Tenderness
Timepoint
At the beginning of the study (before the intervention), three months and six months after the intervention began
Method of measurement
Clinical examinations by the surgeon and registration in a standard checklist designed by the researchers

4

Description
ultrasound findings related to fibrocystic changes in the breast
Timepoint
At the beginning of the study (before the intervention) and six months after the intervention began
Method of measurement
By ultrasonographic scan and recording on a standard checklist designed by the researchers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Consumption of 500 mg oral Metformin tablets twice a day for 6 months.
Category
Treatment - Drugs

2

Description
Control group: Consumption of oral placebo tablets (that are completely similar to the metformin tablets) twice a day for 6 months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr Sadaf Alipour
Street address
No. 162 َAlley (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
salipour@sina.tums.ac.ir
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 Mohammad Ali Sahraian
Street address
6th floor, Central University, Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8838 8988
Fax
+98 21 8838 8988
Email
resdeputy@tums.ac.ir
Web page address
http://vcr.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
Dr Sadaf Alipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash women's hospital, No. 162 َAlley (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
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sadaf Alipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash womens' Hospital, No. 162 َAlley (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
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Sadaf Alipour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Arash Women 's Hospital, No. 162 َAlley (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
salipour@sina.tums.ac.ir
Web page address
http://arash.tums.ac.ir/

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
Not applicable
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