Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

August 16, 2022 updated by: Katherine D. Crew

Pilot Biomarker Modulation Study of Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

The purpose of this study is to determine whether it is feasible to give a combination of Metformin and omega-3 fatty acids for one year to women with a history of early stage breast cancer. We will also evaluate whether the metformin and omega-3 fatty acids combination causes changes in breast tissue, blood, and mammograms.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Metformin is a medication used to treat and prevent diabetes and omega-3 fatty acids has been shown to lower cholesterol and improve cardiovascular health. Research has shown that Metformin and omega-3 fatty acids may also be effective in preventing cancer. In this study, we want to find out what effects, good and/or bad, the Metformin and omega-3 fatty acids combination has on you and your risk of developing a new breast cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • History of histologically-confirmed stage 0, I, II, or III breast carcinoma without evidence of disease at trial entry. Participants with a resected local recurrence are eligible
  • Minimum of 6 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery and no evidence of recurrent disease
  • Minimum of 6 months since completion of adjuvant tamoxifen (tamoxifen is known to lower mammographic density119-121). Current use of a third generation aromatase inhibitor [AI] (i.e., anastrozole, letrozole, exemestane) is permitted provided that the participant has been on a stable dose for the past 6 months
  • Age 21 to 75 years. Both pre- and postmenopausal women will be included in this study. We will exclude perimenopausal women, defined as menstrual cycle irregularity (variable cycle length that differs from normal by more than 7 days) and an Follicle-Stimulating Hormone (FSH) greater than 20 mili international units
  • Negative serum pregnancy testing
  • Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy
  • Eastern Cooperative Oncology Group (ECOG) performance status less than 2
  • Participants must have normal organ and marrow function within 28 days prior to randomization
  • Body mass index (BMI) greater than or equal to 25 kilograms per meter squared or baseline fasting glucose of less than 126 milligrams per deciliter
  • Participants must have a baseline mammographic density greater than or equal to 25 percent based upon the Breast Imaging Reporting and Data System (BIRADS) density score of 2, 3, or 4. Women with a baseline mammographic density of less than 25 percent (BIRADS Score= 1) will not be eligible
  • Willingness to abstain from all omega-3 fish oil supplements for 30 days prior to baseline evaluation and during the study intervention
  • Willingness to comply with all study interventions and follow-up procedures
  • Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • History of histologically-confirmed bilateral breast cancer
  • History of or plans for bilateral mastectomies
  • Evidence of metastatic breast cancer
  • Prior radiation therapy or implant in the contralateral breast
  • Known diabetes (type 1 or 2) or baseline fasting glucose greater than 126 milligrams per deciliter
  • Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association [NYHA] Class III or IV functional status, history of acidosis of any type, intake of 3 or more alcoholic beverages per day on average over the past 6 months)
  • Currently taking metformin, sulfonylureas, thiazolidinediones, or insulin for any reason
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or omega-3 fatty acids
  • Receiving hormone replacement therapy, tamoxifen, or raloxifene within 6 months of trial entry
  • Participants may not be receiving any other investigational agents for 30 days prior to baseline evaluation and during the study intervention
  • Any omega-3 fatty acids should not be taken for 30 days prior to baseline evaluation and during the study intervention. If participants are consuming any of these items and would like to participate in this study, then a 30-day washout period will be required. - Uncontrolled or significant co-morbid illness patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Main Arm
Open Label- Metformin and Omega-3 fatty acids for 12 months post baseline data collection.
Drug: Metformin
Metformin 850mg, oral, twice a day for 12 months
Other Names:
  • N,N-dimethyl biguanide hydrochloride
Drug: Omega-3 fatty acids
Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months
Other Names:
  • Docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants successfully completing the 1-year intervention
Time Frame: 12 months (approximately)
The primary objective is to assess the safety and feasibility of a one-year intervention of metformin and omega-3 fatty acids in early stage breast cancer patients who completed adjuvant treatment.
12 months (approximately)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent in reduction of mammographic density
Time Frame: baseline, 12 months
Determine the efficacy of these drug interventions in reducing mammographic density
baseline, 12 months
Change in fasting serum insulin microunits per milliliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
baseline, month 3, 6, 9, and 12
Change in C-peptide nanograms per milliliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor 1 (IGF-1) nanograms per milliliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor binding protein 1 (IGFBP-1) nanograms per milliliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
baseline, month 3, 6, 9, and 12
Change in insulin-like growth factor binding protein 3 (IGFBP-3) milligrams per liter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating markers of insulin signaling.
baseline, month 3, 6, 9, and 12
Change in fasting serum glucose milligrams per deciliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
baseline, month 3, 6, 9, and 12
Change in total cholesterol milligrams per deciliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
baseline, month 3, 6, 9, and 12
Change in high-density lipoprotein (HDL) milligrams per deciliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
baseline, month 3, 6, 9, and 12
Change in low-density lipoprotein (LDL) milligrams per deciliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
baseline, month 3, 6, 9, and 12
Change in Leptin microunits per liter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
baseline, month 3, 6, 9, and 12
Change in adiponectin micrograms per milliliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating metabolic profile markers.
baseline, month 3, 6, 9, and 12
Change in serum C-reactive protein milligrams per deciliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating inflammatory markers.
baseline, month 3, 6, 9, and 12
Change in Interleukin-6 picograms per milliliter
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating inflammatory markers.
baseline, month 3, 6, 9, and 12
Change in body mass index (BMI)
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating anthropometric measures.
baseline, month 3, 6, 9, and 12
Change in systolic blood pressure
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating anthropometric measures.
baseline, month 3, 6, 9, and 12
Change in diastolic blood pressure
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating anthropometric measures.
baseline, month 3, 6, 9, and 12
Change in homeostatus model assessment (HOMA) score
Time Frame: baseline, month 3, 6, 9, and 12
Determine the efficacy of these drug interventions in modulating anthropometric measures.
baseline, month 3, 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Katherine D. Crew

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Katherine Crew, MD, MS, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 19, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 19, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 30, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAL2650

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings