- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02278965
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
19
Phase
- 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
-
-
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
Ages Eligible for Study
19 years to 73 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 |
Intervention / Treatment |
---|---|
Experimental: Main Arm
Open Label- Metformin and Omega-3 fatty acids for 12 months post baseline data collection.
|
Metformin 850mg, oral, twice a day for 12 months
Other Names:
Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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.
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)
January 22, 2015
Primary Completion (Actual)
April 19, 2017
Study Completion (Actual)
April 19, 2017
Study Registration Dates
First Submitted
October 28, 2014
First Submitted That Met QC Criteria
October 29, 2014
First Posted (Estimate)
October 30, 2014
Study Record Updates
Last Update Posted (Actual)
August 17, 2022
Last Update Submitted That Met QC Criteria
August 16, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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.
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