Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
Primary Purpose
Breast Cancer, Precancerous Condition
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
omega-3 fatty acid
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring ductal breast carcinoma in situ, atypical ductal breast hyperplasia
Eligibility Criteria
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
Sites / Locations
- Epic Imaging
- Knight Cancer Institute at Oregon Health and Science University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm I
Arm II
Arm Description
Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
Outcomes
Primary Outcome Measures
Effect of omega-3 fatty acids on markers of breast cancer progression
Secondary Outcome Measures
Full Information
NCT ID
NCT00627276
First Posted
February 29, 2008
Last Updated
April 25, 2017
Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00627276
Brief Title
Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
Official Title
Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
OBJECTIVES:
To determine the effect of omega-3 fatty acids on markers of breast cancer progression in women with newly diagnosed ductal carcinoma in situ and/or atypical ductal hyperplasia.
To determine the effect of omega-3 fatty acids on specific targets identified by microarray in breast cancer cells and in primary cultures from benign and malignant breast tissue biopsies.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
Arm II: Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
Patients complete questionnaires at baseline, weekly during study treatment, at the completion of study treatment, and then at 30 days after completion of study treatment. These questionnaires include the Fish Oil Adverse Event Questionnaire, the Diet and Family History Questionnaire, the Changes to Diet and Medications Questionnaire, and the Post-Intervention Questionnaire.
Patients undergo blood, urine, nipple aspirate, and tissue sample collection at baseline and after completion of study treatment for translational research studies. Blood samples are analyzed for genetic markers for breast cancer risk and progression by microarray analysis and red blood cell (RBC) fatty acids. Nipple aspirate samples are analyzed for fatty acids to determine the extent to which omega-3 fatty acid supplementation alters the fatty acid profile of breast tissue. Tissue samples are analyzed for the presence of ductal carcinoma in situ and/or atypical ductal hyperplasia or invasive cancer. Leftover blood, urine, nipple aspirate, and tissue samples are stored for future research studies.
After completion of study treatment, patients are followed at 30 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Precancerous Condition
Keywords
ductal breast carcinoma in situ, atypical ductal breast hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
Arm Title
Arm II
Arm Type
Placebo Comparator
Arm Description
Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
omega-3 fatty acid
Intervention Description
Oral, 3 times daily
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Oral, 3 times daily
Primary Outcome Measure Information:
Title
Effect of omega-3 fatty acids on markers of breast cancer progression
Time Frame
minimum 2 weeks, maximum 8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jackilen Shannon, PhD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Epic Imaging
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
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