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


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer, Precancerous Condition

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Effect of omega-3 fatty acids on markers of breast cancer progression

Outcome Time Frame:

minimum 2 weeks, maximum 8 weeks

Safety Issue:

No

Principal Investigator

Jackilen Shannon, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000581419

NCT ID:

NCT00627276

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Precancerous Condition
  • ductal breast carcinoma in situ
  • atypical ductal breast hyperplasia
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Hyperplasia
  • Precancerous Conditions

Name

Location

Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Epic ImagingPortland, Oregon  97220