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

Breast Cancer Clinical Trial

Official title:

Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627276
• Other study ID #: CDR0000581419
• Secondary ID: P30CA069533OHSU-
• Status: Completed
• Phase: N/A
• First received: February 29, 2008
• Last updated: April 25, 2017
• Start date: December 2007
• Est. completion date: November 2013

Study information

• Verified date: July 2015
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Hyperplasia
• Precancerous Condition
• Precancerous Conditions

Intervention

Dietary Supplement:
• omega-3 fatty acid
Oral, 3 times daily

Other:
• placebo
Oral, 3 times daily

Locations

Country	Name	City	State
United States	Epic Imaging	Portland	Oregon
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of omega-3 fatty acids on markers of breast cancer progression		minimum 2 weeks, maximum 8 weeks