Breast CancerNCT03383835
Study of Moderate Dose Omega 3 Fatty Acid Supplement in Premenopausal Women at High Risk for Breast Cancer
A study testing Omega-3 Supplementation in people with Breast Cancer, run by Lauren Nye at 1 site in United States.
Trial summary
This pilot study is an investigation of feasibility of moderate dose omega-3 fatty acid supplementation in pre-menopausal women at high risk for breast cancer who are considering future pregnancy. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omega-3 Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 1 Mar 2024
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women age 21 - 40 must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiol.
- Women must be considered at high risk for breast cancer based on family history (first or second degree relative diagnosed with breast cancer under the age of 60), prior precancerous biopsy or a 5-year Gail model risk estimate of ≥ 1.7% or 10 year Tyrer-Cuzick risk of 2x population risk as listed in the model.
- Women must indicate that they are still considering future pregnancy and childbearing.
- Women must be one year from pregnancy and breast-feeding.
- Women must be willing to take supplemental omega-3 fatty acids provided by the study.
Who cannot join
- Women actively undergoing in-vitro fertilization or fertility treatments are excluded.
- Women currently pregnant or breast-feeding at time of study consent.
- Women with an active malignancy.
- Women on anticoagulation.
- Women with bilateral breast implants or tram flap reconstruction.
- Women who have had radiation to both breasts.
- Women with current mammographic or clinical breast exam mass which is suspicious for breast cancer and malignancy has not been ruled out.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: Feasibility Study of Moderate Dose Omega 3 Fatty Acid Supplementation in Premenopausal Women at High Risk for Breast Cancer Considering Future Pregnancy
This pilot study is an investigation of feasibility of moderate dose omega-3 fatty acid supplementation in pre-menopausal women at high risk for breast cancer who are considering future pregnancy. The goal of this pilot study is to determine feasibility of the study, document compliance with omega-3 fatty acid supplementation in this population and identify novel biomarkers modulated by moderate dose omega-3 fatty acids in this population.
Read the detailed description
Pregnancy and breast feeding are protective when they occur at an early age, typically at an age less than 30. The influence of pregnancy on breast cancer risk is not fully understood, and little is known about modulation of the breast microenvironment during pregnancy and its influence on risk. Hormones, including rising estrogen levels, play a role in fatty acid synthesis. In pre-clinical models, a rise in omega-3:omega-6 ratio occurs naturally in the breast of pregnant mice. This may be able to be accentuated in human breast tissue with omega-3 fatty acid supplementation. Omega-3 fatty acid supplementation has been shown to favorably modulate breast cancer risk and risk biomarkers in pre-menopausal women at high risk for breast. Omega-3 fatty acid supplementation during pregnancy has also been found to have positive outcomes for the offspring, making it an ideal intervention to study in this population.
This pilot study of omega-3 supplementation in pre-menopausal women at high risk for breast cancer who are still considering pregnancy is addressing a potential prevention strategy in a population otherwise excluded from breast cancer prevention trials and not eligible for standard of care chemoprevention. With this pilot, the intent is to establish feasibility, document tolerability, determine number of women needed to enroll based on pregnancy rate and identify biomarkers for future investigation. This information will provide necessary data to apply for future extramural funding for a larger randomized trial. In a larger randomized trial with longer follow up, we will be able to assess post-pregnancy breast tissue and biomarkers to examine efficacy of omega-3 fatty acid supplementation in breast cancer risk reduction.
- Conditions
- Breast Cancer
- Being tested
- Omega-3 Supplementation
- Keywords
- Omega 3 supplement, pre-menopausal, pregnancy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 SupplementationDietary supplement
DHA 600 milligrams (mg) per day for 6 months
EPA 300mg per day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Supplementation | Experimental | Participants will take the dose of omega-3 supplementation (600mg DHA and 300mg EPA) daily for 6 months. Receives: Dietary Supplement: Omega-3 Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up visit completion rate
Defined as the overall completion of 80% of follow-up visits study-wide.
Measured: 6 months
Secondary outcomes (4)
Pregnancy rate
Pregnancy will be assessed by review of patient record.
Measured: 6 months
Discontinuation rate of omega-3 supplementation
Discontinuation rate will be assessed by patient reported compliance.
Measured: 6 months
Incidence of microbiome in collected breast tissue
Microbiome will be assessed with random periareolar fine-needle aspiration (RPFNA)
Measured: 6 months
Identify presence of biomarkers
Biomarkers will be assessed by RPFNA
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start5 Feb 2018
- Primary completion8 Aug 2019
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauren Nye
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, American Cancer Society, Inc.
- Responsible party
- Sponsor-investigator, Lauren Nye, University of Kansas Medical Center
- Investigators
- Lauren Nye, MD, Principal investigator, The University of Kansas - Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383835
- Sponsor's protocol ID
- Moderate Dose Omega-3
- Status last verified
- May 2023
- First submitted
- 19 Dec 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Moderate Dose Omega 3 Fatty Acid Supplementation in Premenopausal Women at High Risk for Breast Cancer Considering Future Pregnancy
- ClinicalTrials.gov ID
- NCT03383835
- Acronym / sponsor ID
- Moderate Dose Omega-3
- Conditions
- Breast Cancer
- Keywords
- Omega 3 supplement, pre-menopausal, pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Lauren NyeUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, American Cancer Society, Inc.
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 26 Dec 2017 (actual)
- 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.
This pilot study is an investigation of feasibility of moderate dose omega-3 fatty acid supplementation in pre-menopausal women at high risk for breast cancer who are considering future pregnancy. The goal of this pilot study is to determine feasibility of the study, document compliance with omega-3 fatty acid supplementation in this population and identify novel biomarkers modulated by moderate dose omega-3 fatty acids in this population.
Detailed description
Pregnancy and breast feeding are protective when they occur at an early age, typically at an age less than 30. The influence of pregnancy on breast cancer risk is not fully understood, and little is known about modulation of the breast microenvironment during pregnancy and its influence on risk. Hormones, including rising estrogen levels, play a role in fatty acid synthesis. In pre-clinical models, a rise in omega-3:omega-6 ratio occurs naturally in the breast of pregnant mice. This may be able to be accentuated in human breast tissue with omega-3 fatty acid supplementation. Omega-3 fatty acid supplementation has been shown to favorably modulate breast cancer risk and risk biomarkers in pre-menopausal women at high risk for breast. Omega-3 fatty acid supplementation during pregnancy has also been found to have positive outcomes for the offspring, making it an ideal intervention to study in this population.
This pilot study of omega-3 supplementation in pre-menopausal women at high risk for breast cancer who are still considering pregnancy is addressing a potential prevention strategy in a population otherwise excluded from breast cancer prevention trials and not eligible for standard of care chemoprevention. With this pilot, the intent is to establish feasibility, document tolerability, determine number of women needed to enroll based on pregnancy rate and identify biomarkers for future investigation. This information will provide necessary data to apply for future extramural funding for a larger randomized trial. In a larger randomized trial with longer follow up, we will be able to assess post-pregnancy breast tissue and biomarkers to examine efficacy of omega-3 fatty acid supplementation in breast cancer risk reduction.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Supplementation | Experimental | Dietary Supplement: Omega-3 SupplementationParticipants will take the dose of omega-3 supplementation (600mg DHA and 300mg EPA) daily for 6 months. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women age 21 - 40 must be pre-menopausal as defined as having intact ovaries with regular menses or if not menstruating, have a premenopausal status confirmed by serum follicle-stimulating hormone (FSH) and estradiol.
- Women must be considered at high risk for breast cancer based on family history (first or second degree relative diagnosed with breast cancer under the age of 60), prior precancerous biopsy or a 5-year Gail model risk estimate of ≥ 1.7% or 10 year Tyrer-Cuzick risk of 2x population risk as listed in the model.
- Women must indicate that they are still considering future pregnancy and childbearing.
- Women must be one year from pregnancy and breast-feeding.
- Women must be willing to take supplemental omega-3 fatty acids provided by the study.
Key exclusion criteria (7 listed)
- Women actively undergoing in-vitro fertilization or fertility treatments are excluded.
- Women currently pregnant or breast-feeding at time of study consent.
- Women with an active malignancy.
- Women on anticoagulation.
- Women with bilateral breast implants or tram flap reconstruction.
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 SupplementationDHA 600 milligrams (mg) per day for 6 months EPA 300mg per day for 6 months | Dietary supplement | Omega-3 Supplementation |
Primary outcome
Follow-up visit completion rate
Time frame: 6 months
Defined as the overall completion of 80% of follow-up visits study-wide.
4 secondary outcomes
Pregnancy rate
Time frame: 6 months
Discontinuation rate of omega-3 supplementation
Time frame: 6 months
Incidence of microbiome in collected breast tissue
Time frame: 6 months
Identify presence of biomarkers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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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.
Lauren Nye, MD principal investigator
The University of Kansas - Cancer 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 Supplementation in people with Breast Cancer, run by Lauren Nye 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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 23 May 2023. 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?
Results are not available in the source record.
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?
Follow-up visit completion rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2023.