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

Sponsor:	OHSU Knight Cancer Institute
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00627276

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	Phase
Breast Cancer Precancerous Condition	Dietary Supplement: omega-3 fatty acids Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Effect of omega-3 fatty acids on markers of breast cancer progression [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.	Dietary Supplement: omega-3 fatty acids Oral, 3 times daily
Arm II: Placebo Comparator 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	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Jackilen Shannon, PhD 503-494-4993 shannoja@ohsu.edu

Sponsors and Collaborators

OHSU Knight Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Jackilen Shannon, PhD

OHSU Knight Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000581419, OHSU-3872, OHSU-CTRC-1037
Study First Received:	February 29, 2008
Last Updated:	January 27, 2010
ClinicalTrials.gov Identifier:	NCT00627276 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

ductal breast carcinoma in situ
atypical ductal breast hyperplasia

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Precancerous Conditions
Skin Diseases
Breast Neoplasms
Carcinoma
Hyperplasia
Neoplasms
Pathologic Processes

Neoplasms by Site
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms, Ductal, Lobular, and Medullary
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010