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

• Sponsor: OHSU Knight Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00627276
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 16
• Locations: 2
• Arms: 2
• Duration (Months): 71
• Patients Per Site: 8
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Precancerous Condition	Dietary Supplement: omega-3 fatty acid; Other: placebo	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach
• Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Effect of omega-3 fatty acids on markers of breast cancer progression [minimum 2 weeks, maximum 8 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 120 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Epic Imaging	Portland	Oregon	United States	97220
2	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon	United States	97239-3098

Sponsors and Collaborators

• OHSU Knight Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Jackilen Shannon, PhD, OHSU Knight Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute
• ClinicalTrials.gov Identifier: NCT00627276
• Other Study ID Numbers: CDR0000581419; P30CA069533; OHSU-3872; OHSU-CTRC-1037; NCI-2013-00768
• First Posted: Mar 3, 2008
• Last Update Posted: Apr 27, 2017
• Last Verified: Jul 1, 2015

• Keywords provided by Jackie Shannon, Principal Investigator, OHSU Knight Cancer Institute: ductal breast carcinoma in situ; atypical ductal breast hyperplasia
• Additional relevant MeSH terms: Carcinoma in Situ; Precancerous Conditions

Study Results

No Results Posted as of Apr 27, 2017