Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments omega-3 fatty acids, placebo capsule, diet and exercise
Phase phase 2
Sponsor Carol Fabian, MD
Collaborator DSM Nutritional Products, Inc.
Start date March 2014
End date November 2016
Trial size 50 participants
Trial identifier NCT02101970, STUDY00000703

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
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)
omega-3 fatty acids Eicosapentaenoic Acid (EPA)
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)
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.
(Active Comparator)
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.
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.

Primary Outcomes

Measure
Dropout rate
time frame: Up to 6 Months

Secondary Outcomes

Measure
Study design feasibility
time frame: Up to 6 months
Modulation of breast cancer risk biomarkers
time frame: Change from Baseline to 6 Months
Modulation of breast cancer risk biomarkers in benign breast tissue
time frame: Change from Baseline to 6 Months
Modulation of breast cancer risk biomarkers
time frame: Change from Baseline to 12 Months
Modulation of breast cancer risk biomarkers in benign breast tissue
time frame: Change from Baseline to 12 Months
Weight gain
time frame: Change from 6 Months to 12 Months
Change in Gut Microbiome
time frame: Change from Baseline to Month 6

Eligibility Criteria

Female participants from 45 years up to 70 years old.

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.

Additional Information

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
Principal investigator Carol J. Fabian, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.