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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00627276
First received: February 29, 2008
Last updated: May 6, 2014
Last verified: May 2014

February 29, 2008
May 6, 2014
December 2007
December 2012   (final data collection date for primary outcome measure)
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 ]
Effect of omega-3 fatty acids on markers of breast cancer progression [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00627276 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Breast Cancer
  • Precancerous Condition
  • Dietary Supplement: omega-3 fatty acid
    Oral, 3 times daily
  • Other: placebo
    Oral, 3 times daily
  • Experimental: Arm I
    Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
    Intervention: Dietary Supplement: omega-3 fatty acid
  • Placebo Comparator: Arm II
    Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
Female
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00627276
CDR0000581419, P30CA069533, OHSU-3872, OHSU-CTRC-1037
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Jackilen Shannon, PhD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP