Breast CancerNCT02101970
Weight Loss Plus Omega-3 Fatty Acids or Placebo in High Risk Women
A study testing Omega-3 Fatty Acids and Diet and Exercise in people with Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omega-3 Fatty Acids and Diet and Exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 27 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center, Breast Cancer Prevention Center
Kansas City, Kansas, 66205
About this study
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
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Omega-3 Fatty Acids, Placebo Capsule, Diet and Exercise
- Keywords
- Breast cancer risk, DHA, Omega-3 Fatty Acids, EPA, Weight Loss
- Medical subject headings
- Breast Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty AcidsDietary supplement
Also called Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)
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)
Placebo CapsuleOther
Diet and ExerciseOther
Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.
| Study group | Role | What they receive |
|---|---|---|
| Weight Loss + Omega-3 FA | 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) Receives: Dietary Supplement: Omega-3 Fatty Acids; Other: Diet and Exercise |
| Weight Loss + Placebo | 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. Receives: Other: Placebo Capsule; Other: Diet and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dropout rate
Measured as the number of participants that dropout before diet+intervention period is complete
Measured: Up to 6 Months
Secondary outcomes (7)
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
Measured: Up to 6 months
Modulation of breast cancer risk biomarkers
Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
Measured: Change from Baseline to 6 Months
Modulation of breast cancer risk biomarkers in benign breast tissue
Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
Measured: Change from Baseline to 6 Months
Modulation of breast cancer risk biomarkers
Measure the change in fasting and postprandial blood inflammatory, and risk biomarkers
Measured: Change from Baseline to 12 Months
Modulation of breast cancer risk biomarkers in benign breast tissue
Measure change in fasting and postprandial blood inflammatory, and risk biomarkers
Measured: Change from Baseline to 12 Months
Weight gain
Measure change in weight in participants during the 6-12 month maintenance phase
Measured: Change from 6 Months to 12 Months
Change in Gut Microbiome
Change in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA):arachidonic acid (AA) ratio
Measured: Change from Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completion27 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carol Fabian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor-investigator, Carol Fabian, MD, University of Kansas Medical Center
- Investigators
- Carol J. Fabian, M.D., Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101970
- Sponsor's protocol ID
- STUDY00000703
- Status last verified
- Jan 2022
- First submitted
- 28 Mar 2014
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Global results will be published.
Publications
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.
PubMed 34244155
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02101970
- Acronym / sponsor ID
- STUDY00000703
- Conditions
- Breast Cancer
- Keywords
- Breast cancer risk, DHA, Omega-3 Fatty Acids, EPA, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Carol Fabian, MDUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- Mar 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 27 Aug 2018 (actual)
- First posted
- 2 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Loss + Omega-3 FA | Experimental | Dietary Supplement: Omega-3 Fatty Acids, Other: Diet and ExerciseParticipants 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) |
| Weight Loss + Placebo | Active comparator | Other: Placebo Capsule, Other: Diet and ExerciseParticipants 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty AcidsAlso: Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA)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) | Dietary supplement | Weight Loss + Omega-3 FA |
| Placebo Capsule | Other | Weight Loss + Placebo |
| Diet and ExerciseIncreasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods. | Other | Weight Loss + Omega-3 FA, Weight Loss + Placebo |
Primary outcome
Dropout rate
Time frame: Up to 6 Months
Measured as the number of participants that dropout before diet+intervention period is complete
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Results publication: PubMed 34244155Fabian 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.
- Individual participant dataSharing planned: No. Global results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol J. Fabian, M.D. principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty Acids and Diet and Exercise in people with Breast Cancer, run by Carol Fabian, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dropout rate (time frame: Up to 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02101970, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.