Evidence map›Paper›PMID 26438592›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2015

Modulation of Breast Cancer Risk Biomarkers by High-Dose Omega-3 Fatty Acids: Phase II Pilot Study in Premenopausal Women.

Carol J Fabian, Bruce F Kimler, Teresa A Phillips, Jessica A Box, Amy L Kreutzjans, Susan E Carlson, Brandon H Hidaka, Trina Metheny, Carola M Zalles, Gordon B Mills and 6 more

Abstract readClinical TrialClinical Trial, Phase II
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Promising Effects ofMolecules (Basel, Switzerland) · 2023
    Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Carol J FabianDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas. cfabian@kumc.edu.
Bruce F KimlerDepartment of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas.
Teresa A PhillipsDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Jessica A BoxDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Amy L KreutzjansDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Susan E CarlsonDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.
Brandon H HidakaDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.
Trina MethenyDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Carola M ZallesMercy Hospital, Miami, Florida.
Gordon B MillsDepartment of Systems Biology, University of Texas MD Anderson Cancer Center, Houston, Texas.
Kandy R PowersDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Debra K SullivanDepartment of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.
Brian K PetroffDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Whitney L HensingDepartment of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.
Brooke L FridleyDepartment of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas.
Stephen D HurstingDepartment of Nutrition, University of North Carolina, Chapel Hill, North Carolina.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Akt/mTOR Signaling in Energy Balance Modulation of Epithelial CarcinogenesisR01CA129409 · NCI · UNIVERSITY OF TEXAS AT AUSTIN · PI HURSTING, STEPHEN D · 2009 to 2013
$1.6M
NCI NIH HHS P30 CA016672NCI NIH HHS P30 CA16672NCI NIH HHS R01 CA129409
6 · The paper itself

Abstract

Higher intakes of the omega-3 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) relative to the omega-6 arachidonic acid (AA) have been variably associated with reduced risk of premenopausal breast cancer. The purpose of this pilot trial was to assess feasibility and explore the effects of high-dose EPA and DHA on blood and benign breast tissue risk biomarkers before design of a placebo-controlled phase IIB trial. Premenopausal women with evidence of hyperplasia ± atypia by baseline random periareolar fine needle aspiration were given 1860 mg of EPA + 1500 mg of DHA ethyl esters daily for 6 months. Blood and benign breast tissue were sampled during the same menstrual cycle phase prestudy and a median of 3 weeks after last dose. Additional blood was obtained within 24 hours of last dose. Feasibility, which was predefined as 50% uptake, 85% retention, and 70% compliance, was demonstrated with 46% uptake, 94% completion, and 85% compliance. Cytologic atypia decreased from 77% to 38% (P = 0.002), and Ki-67 from a median of 2.1% to 1.0% (P = 0.021) with an increase in the ratio of EPA + DHA to AA in erythrocyte phospholipids but no change in blood hormones, adipokines, or cytokines. Exploratory breast proteomics assessment showed decreases in several proteins involved in hormone and cytokine signaling with mixed effects on those in the AKT/mTOR pathways. Further investigation of EPA plus DHA for breast cancer prevention in a placebo-controlled trial in premenopausal women is warranted.

Indexed as

AdultBiomarkers, TumorBreast NeoplasmsChromatography, Thin LayerDocosahexaenoic AcidsDrug CombinationsEicosapentaenoic AcidEnzyme-Linked Immunosorbent AssayFatty Acids, Omega-3Feasibility StudiesFemaleHumansHyperplasiaKi-67 AntigenMiddle AgedPilot ProjectsBiomarkers, TumorDocosahexaenoic AcidsDrug CombinationsEicosapentaenoic AcidFatty Acids, Omega-3Ki-67 AntigenOmacor

Identifiers

PMID26438592
PMCPMC6053670

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.