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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101970
• Other study ID #: STUDY00000703
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 27, 2018

Study information

• Verified date: January 2022
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 27, 2018
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Weight Loss

Intervention

Dietary Supplement:
• Omega-3 Fatty Acids
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)

Other:
• Placebo Capsule

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center, Breast Cancer Prevention Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Carol Fabian, MD	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Inter — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dropout rate	Measured as the number of participants that dropout before diet+intervention period is complete	Up to 6 Months
Secondary	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	Up to 6 months
Secondary	Modulation of breast cancer risk biomarkers	Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers	Change from Baseline to 6 Months
Secondary	Modulation of breast cancer risk biomarkers in benign breast tissue	Measure change in fasting and postprandial blood inflammatory, and risk biomarkers	Change from Baseline to 6 Months
Secondary	Modulation of breast cancer risk biomarkers	Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers	Change from Baseline to 12 Months
Secondary	Modulation of breast cancer risk biomarkers in benign breast tissue	Measure change in fasting and postprandial blood inflammatory, and risk biomarkers	Change from Baseline to 12 Months
Secondary	Weight gain	Measure change in weight in participants during the 6-12 month maintenance phase	Change from 6 Months to 12 Months
Secondary	Change in Gut Microbiome	Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio	Change from Baseline to Month 6