Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00627276
First received: February 29, 2008
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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 phase II 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.


Condition Intervention
Breast Cancer
Precancerous Condition
Dietary Supplement: omega-3 fatty acid
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Effect of omega-3 fatty acids on markers of breast cancer progression [ Time Frame: minimum 2 weeks, maximum 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: December 2007
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
Dietary Supplement: omega-3 fatty acid
Oral, 3 times daily
Placebo Comparator: Arm II
Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
Other: placebo
Oral, 3 times daily

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 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627276

Locations
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Epic Imaging
Portland, Oregon, United States, 97220
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00627276     History of Changes
Other Study ID Numbers: CDR0000581419, P30CA069533, OHSU-3872, OHSU-CTRC-1037
Study First Received: February 29, 2008
Last Updated: April 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by OHSU Knight Cancer Institute:
ductal breast carcinoma in situ
atypical ductal breast hyperplasia

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Hyperplasia
Precancerous Conditions
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014