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Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Omega-3 Fatty Acids

Placebo Capsule

Diet and Exercise

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Breast cancer risk, DHA, Omega-3 Fatty Acids, EPA, Weight Loss

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

Evidence of Hyperplasia with Masood score of 13 or higher and 500 or more epithelial cells on cytology slide of screening Random Periareolar Fine Needle Aspiration (RPFNA)
Access to smart phone and or computer
Willing to comply with diet, exercise and lifestyle modification during weight reduction and maintenance phase.
Willing to start the dietary and exercise intervention within 9 months of RPFNA
Willing to complete quality of life questionnaires at multiple visits
Willing to have a medical history and physical at multiple visits
Willing to have an additional RPFNA at two additional visits
Be willing to have blood drawn at multiple visits
Willing to sign and able to understand consent for the RPFNA's and study participation
Reasonable hematopoetic, kidney and liver function consistent with safe participation on this trial.

Exclusion Criteria:

Having taken medications that seriously affect metabolism such as steroids, dexatrim or other diet drugs within 3 weeks of study registration
Have changed dose or type of hormone supplementation within 3 months
Currently receiving other investigational agents
Have been on a chemoprevention trial within 6 months or taken a Selective Estrogen Receptor Modulator or aromatase inhibitor within last 6 months.
Need for chronic use of aspirin, nonsteroidal anti-inflamatory drug (NSAID) or other anti-inflammatory agents
Taking metformin, or other diabetes medications
Taking statins
Unable to participate in moderate intensity exercise (walking, treadmill, elliptical, water aerobics)
Would be unable to participate, by phone, in weekly phone call sessions
Cells suspicious for malignancy as assessed by cytotechnologist or cytopathologist.

Sites / Locations

University of Kansas Medical Center, Breast Cancer Prevention Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Weight Loss + Omega-3 FA

Weight Loss + Placebo

Arm Description

Participants will be instructed to follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of Omega-3 FA (fatty acids) a day beginning 2 weeks after starting their diet and exercise routine. Omega-3 FA will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.Each Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)

Participants will be instructed to exercise and follow a diet that is reduced by 500-700 kcal/day below maintenance requirements for 24 weeks or until the individual has reached a BMI of 25kg/m2 (generally 1000-2000 calories/day). Participants will be given one capsule of placebo a day beginning 2 weeks after starting their diet and exercise routine. Placebo capsule will be increased by 1 capsule/day or every other day until participant is taking 5 capsules per day.

Outcomes

Primary Outcome Measures

Dropout rate

Measured as the number of participants that dropout before diet+intervention period is complete

Secondary Outcome Measures

Study design feasibility

Based on eligibility criteria, study procedures and participation of subjects the study design will be measured to see if it will practically work with a larger study population

Modulation of breast cancer risk biomarkers

Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers

Modulation of breast cancer risk biomarkers in benign breast tissue

Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

Modulation of breast cancer risk biomarkers

Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers

Modulation of breast cancer risk biomarkers in benign breast tissue

Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

Weight gain

Measure change in weight in participants during the 6-12 month maintenance phase

Change in Gut Microbiome

Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio

Full Information

NCT ID

NCT02101970

First Posted

March 28, 2014

Last Updated

January 6, 2022

Sponsor

Carol Fabian, MD

Collaborators

DSM Nutritional Products, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02101970

Brief Title

Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

Official Title

Randomized Pilot Trial of Omega-3 Fatty Acids or Placebo in Peri- or Post-Menopausal Women at High Risk for Breast Cancer Undergoing a Weight Loss Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Carol Fabian, MD

Collaborators

DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine if high dose supplementation with the omega-3 fatty acids EPA and DHA, when added to a weight loss program, is well tolerated in the study population and if there is an increase in the favorable change in blood and tissue breast cancer risk factors when compared to weight loss alone.

Detailed Description

Subjects will all participate in a 6-month weight loss intervention. Subjects will be randomized to receive either blinded placebo or omega-3 fatty acids for 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Breast cancer risk, DHA, Omega-3 Fatty Acids, EPA, Weight Loss

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Weight Loss + Omega-3 FA

Arm Type

Experimental

Arm Description

Arm Title

Weight Loss + Placebo

Arm Type

Active Comparator

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

Omega-3 Fatty Acids

Other Intervention Name(s)

Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)

Intervention Description

Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)

Intervention Type

Other

Intervention Name(s)

Placebo Capsule

Intervention Type

Other

Intervention Name(s)

Diet and Exercise

Intervention Description

Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.

Primary Outcome Measure Information:

Title

Dropout rate

Description

Measured as the number of participants that dropout before diet+intervention period is complete

Time Frame

Up to 6 Months

Secondary Outcome Measure Information:

Title

Study design feasibility

Description

Based on eligibility criteria, study procedures and participation of subjects the study design will be measured to see if it will practically work with a larger study population

Time Frame

Up to 6 months

Title

Modulation of breast cancer risk biomarkers

Description

Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers

Time Frame

Change from Baseline to 6 Months

Title

Modulation of breast cancer risk biomarkers in benign breast tissue

Description

Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

Time Frame

Change from Baseline to 6 Months

Title

Modulation of breast cancer risk biomarkers

Description

Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers

Time Frame

Change from Baseline to 12 Months

Title

Modulation of breast cancer risk biomarkers in benign breast tissue

Description

Measure change in fasting and postprandial blood inflammatory, and risk biomarkers

Time Frame

Change from Baseline to 12 Months

Title

Weight gain

Description

Measure change in weight in participants during the 6-12 month maintenance phase

Time Frame

Change from 6 Months to 12 Months

Title

Change in Gut Microbiome

Description

Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio

Time Frame

Change from Baseline to Month 6

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Evidence of Hyperplasia with Masood score of 13 or higher and 500 or more epithelial cells on cytology slide of screening Random Periareolar Fine Needle Aspiration (RPFNA) Access to smart phone and or computer Willing to comply with diet, exercise and lifestyle modification during weight reduction and maintenance phase. Willing to start the dietary and exercise intervention within 9 months of RPFNA Willing to complete quality of life questionnaires at multiple visits Willing to have a medical history and physical at multiple visits Willing to have an additional RPFNA at two additional visits Be willing to have blood drawn at multiple visits Willing to sign and able to understand consent for the RPFNA's and study participation Reasonable hematopoetic, kidney and liver function consistent with safe participation on this trial. Exclusion Criteria: Having taken medications that seriously affect metabolism such as steroids, dexatrim or other diet drugs within 3 weeks of study registration Have changed dose or type of hormone supplementation within 3 months Currently receiving other investigational agents Have been on a chemoprevention trial within 6 months or taken a Selective Estrogen Receptor Modulator or aromatase inhibitor within last 6 months. Need for chronic use of aspirin, nonsteroidal anti-inflamatory drug (NSAID) or other anti-inflammatory agents Taking metformin, or other diabetes medications Taking statins Unable to participate in moderate intensity exercise (walking, treadmill, elliptical, water aerobics) Would be unable to participate, by phone, in weekly phone call sessions Cells suspicious for malignancy as assessed by cytotechnologist or cytopathologist.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carol J. Fabian, M.D.

Organizational Affiliation

University of Kansas Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kansas Medical Center, Breast Cancer Prevention Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66205

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Global results will be published.

Citations:

PubMed Identifier

34244155

Citation

Fabian CJ, Befort CA, Phillips TA, Nydegger JL, Kreutzjans AL, Powers KR, Metheny T, Klemp JR, Carlson SE, Sullivan DK, Zalles CM, Giles ED, Hursting SD, Hu J, Kimler BF. Change in Blood and Benign Breast Biomarkers in Women Undergoing a Weight-Loss Intervention Randomized to High-Dose omega-3 Fatty Acids versus Placebo. Cancer Prev Res (Phila). 2021 Sep;14(9):893-904. doi: 10.1158/1940-6207.CAPR-20-0656. Epub 2021 Jul 9.

Results Reference

result

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Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women

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