Study of Moderate Dose Omega 3 Fatty Acid Supplement in Premenopausal Women at High Risk for Breast Cancer

NCT03383835 | Unknown DMC

• 1 other identifier: Moderate Dose Omega-3
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer

Keywords

Omega 3 supplement; pre-menopausal; pregnancy

Outcome Measures

Primary Outcomes (1)

• Follow-up visit completion rate

  Defined as the overall completion of 80% of follow-up visits study-wide.

  6 months

Secondary Outcomes (4)

• Pregnancy rate

  6 months

• Discontinuation rate of omega-3 supplementation

  6 months

• Incidence of microbiome in collected breast tissue

  6 months

• Identify presence of biomarkers

  6 months

Study Arms (1)

Omega-3 Supplementation

EXPERIMENTAL

Participants will take the dose of omega-3 supplementation (600mg DHA and 300mg EPA) daily for 6 months.

Dietary Supplement: Omega-3 Supplementation

Interventions

Omega-3 Supplementation DIETARY_SUPPLEMENT

DHA 600 milligrams (mg) per day for 6 months EPA 300mg per day for 6 months

Omega-3 Supplementation

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lauren Nye: lead
• University of Kansas Medical Center: collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lauren Nye, MD

  The University of Kansas - Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: February 5, 2018
• Primary Completion: August 8, 2019
• Study Completion: March 1, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

US (1)