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 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Oregon
-
Portland, Oregon, Forenede Stater, 97239-3098
- Knight Cancer Institute At Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97220
- EPIC Imaging
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm I
Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
|
Oral, 3 times daily
|
|
Placebo komparator: Arm II
Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
|
Oral, 3 times daily
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Effect of omega-3 fatty acids on markers of breast cancer progression
Tidsramme: minimum 2 weeks, maximum 8 weeks
|
minimum 2 weeks, maximum 8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CDR0000581419
- P30CA069533 (U.S. NIH-bevilling/kontrakt)
- OHSU-3872 (Anden identifikator: OHSU IRB)
- OHSU-CTRC-1037 (Anden identifikator: OHSU OCTRI CTRC number)
- NCI-2013-00768 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
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