Breast CancerNCT00627276
Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
A study testing omega-3 fatty acid in people with Breast Cancer and Precancerous Condition, run by OHSU Knight Cancer Institute at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Precancerous Condition
- What is being tested?
- omega-3 fatty acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Epic Imaging
Portland, Oregon, 97220
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, 97239-3098
About this study
Official title: 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 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.
Read the 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.
- Conditions
- Breast Cancer, Precancerous Condition
- Being tested
- omega-3 fatty acid, placebo
- Keywords
- ductal breast carcinoma in situ, atypical ductal breast hyperplasia
- Medical subject headings
- Breast Neoplasms, Precancerous Conditions, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidDietary supplement
Oral, 3 times daily
placeboOther
Oral, 3 times daily
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks. Receives: Dietary Supplement: omega-3 fatty acid |
| Arm II | Placebo comparator | Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of omega-3 fatty acids on markers of breast cancer progression
Measured: minimum 2 weeks, maximum 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jackie Shannon, OHSU Knight Cancer Institute
- Investigators
- Jackilen Shannon, PhD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627276
- Sponsor's protocol ID
- CDR0000581419
- Other IDs
- P30CA069533, OHSU-3872, OHSU-CTRC-1037, NCI-2013-00768
- Status last verified
- Jul 2015
- First submitted
- 29 Feb 2008
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach
- ClinicalTrials.gov ID
- NCT00627276
- Acronym / sponsor ID
- CDR0000581419
- Conditions
- Breast Cancer, Precancerous Condition
- Keywords
- ductal breast carcinoma in situ, atypical ductal breast hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: omega-3 fatty acidPatients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks. |
| Arm II | Placebo comparator | Other: placeboPatients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks. |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 fatty acidOral, 3 times daily | Dietary supplement | Arm I |
| placeboOral, 3 times daily | Other | Arm II |
Primary outcome
Effect of omega-3 fatty acids on markers of breast cancer progression
Time frame: minimum 2 weeks, maximum 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jackilen Shannon, PhD principal investigator
OHSU Knight Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acid in people with Breast Cancer and Precancerous Condition, run by OHSU Knight Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of omega-3 fatty acids on markers of breast cancer progression (time frame: minimum 2 weeks, maximum 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.