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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Oregon
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Portland, Oregon, Forente stater, 97239-3098
- Knight Cancer Institute at Oregon Health and Science University
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Portland, Oregon, Forente stater, 97220
- EPIC Imaging
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000581419
- P30CA069533 (U.S. NIH-stipend/kontrakt)
- OHSU-3872 (Annen identifikator: OHSU IRB)
- OHSU-CTRC-1037 (Annen identifikator: OHSU OCTRI CTRC number)
- NCI-2013-00768 (Registeridentifikator: Clinical Trials Reporting Program (CTRP))
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