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

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ClinicalTrials.gov Identifier: NCT02278965
Recruitment Status : Active, not recruiting
First Posted : October 30, 2014
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stage 0 Breast Carcinoma Breast Neoplasms Stage I Breast Carcinoma Stage II Breast Carcinoma Stage III Breast Carcinoma Drug: Metformin Drug: Omega-3 fatty acids Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Biomarker Modulation Study of Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer
Actual Study Start Date : January 22, 2015
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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 Name: 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 Name: Docosahexaenoic acid (DHA)/eicosapentaenoic acid (EPA)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percent in reduction of mammographic density [ Time Frame: baseline, 12 months ]
    Determine the efficacy of these drug interventions in reducing mammographic density

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278965


Locations
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United States, New York
Columbia University
New York, New York, United States, 10032
Sponsors and Collaborators
Katherine D. Crew
Investigators
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Principal Investigator: Katherine Crew, MD, MS Columbia University

Additional Information:
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Responsible Party: Katherine D. Crew, Assistant Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT02278965     History of Changes
Other Study ID Numbers: AAAL2650
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katherine D. Crew, Columbia University:
Breast Cancer
Early Stage

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Metformin
Carcinoma
Breast Carcinoma In Situ
Breast Diseases
Skin Diseases
Carcinoma in Situ
Hypoglycemic Agents
Physiological Effects of Drugs