NCT00627276

Brief Summary

RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of abnormal breast cells. PURPOSE: This randomized pilot trial is studying how well omega-3 fatty acids work in treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal hyperplasia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 27, 2017

Status Verified

July 1, 2015

Enrollment Period

5 years

First QC Date

February 29, 2008

Last Update Submit

April 25, 2017

Conditions

Breast CancerPrecancerous Condition

Keywords

ductal breast carcinoma in situatypical ductal breast hyperplasia

Outcome Measures

Primary Outcomes (1)

  • Effect of omega-3 fatty acids on markers of breast cancer progression

    minimum 2 weeks, maximum 8 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.

Dietary Supplement: omega-3 fatty acid

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.

Other: placebo

Interventions

omega-3 fatty acidDIETARY_SUPPLEMENT

Oral, 3 times daily

Arm I
placeboOTHER

Oral, 3 times daily

Arm II

Eligibility Criteria

Age21 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Biopsy confirmed diagnosis of any of the following: * Ductal carcinoma in situ (DCIS) and/or atypical ductal hyperplasia (ADH) * DCIS with a component of invasive carcinoma * ADH with a component of invasive carcinoma * DCIS and ADH with a component of invasive carcinoma * Newly diagnosed disease * No pure invasive breast cancer on biopsy without a component of DCIS or ADH * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Not pregnant * Negative pregnancy test * Speaks English or Spanish * No allergy to fish oil or olive oil * No condition that, in the opinion of the study clinician, would make participation in the study harmful to the patient PRIOR CONCURRENT THERAPY: * No concurrent therapeutic anticoagulation * No concurrent use of fish oil \> 1 g/day

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Epic Imaging

Portland, Oregon, 97220, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsPrecancerous ConditionsCarcinoma, Intraductal, Noninfiltrating

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Jackilen Shannon, PhD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 29, 2008

First Posted

March 3, 2008

Study Start

December 1, 2007

Primary Completion

December 1, 2012

Study Completion

November 1, 2013

Last Updated

April 27, 2017

Record last verified: 2015-07

Locations

US(2)