Evidence map›Paper›PMID 22669332›Full record

Trial reportEuropean journal of clinical nutrition2012

Administration of omega-3 fatty acids and Raloxifene to women at high risk of breast cancer: interim feasibility and biomarkers analysis from a clinical trial.

C Signori, C DuBrock, J P Richie, B Prokopczyk, L M Demers, C Hamilton, T J Hartman, J Liao, K El-Bayoumy, A Manni

Open access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical nutrition, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 7 pooled it
4.2field-weighted citation impact, top 5% of its field
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

25 citing papers in PubMed, 7 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Pooled it
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  6. Factors affecting uptake and adherence to breast cancer chemoprevention: a systematic review and meta-analysis.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
    Pooled it
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  11. Promising Effects ofMolecules (Basel, Switzerland) · 2023
    Review
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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

10 authors at 1 institution in 1 country.

C SignoriDepartment of Medicine, Hershey, PA, USA.
C DuBrock
J P Richie
B Prokopczyk
L M Demers
C Hamilton
T J Hartman
J Liao
K El-Bayoumy
A Manni
Hershey (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesThe antiestrogen, Raloxifene (Ral) is an effective breast cancer chemopreventive agent. Omega-3 fatty acids (n-3FA) may inhibit mammary carcinogenesis. On the basis of their mechanisms of action, we test the hypothesis that a combination of n-3FA and Ral may be superior in reducing select biomarkers of breast cancer risk in women. SUBJECTS/

methodsPostmenopausal women at increased risk for breast cancer (breast density ≥ 25%) were randomized to: (1) no intervention; (2) Ral 60 mg; (3) Ral 30 mg; (4) n-3FA (Lovaza) 4 g and (5) Lovaza 4 g+Ral 30 mg for 2 years. Reduction in breast density is the primary end point of the study. We report preliminary data on feasibility, compliance and changes in secondary end points related to IGF-I signaling, estrogen metabolism, oxidative stress and inflammation in the first group of 46 women who completed 1 year of the study.

resultsAll interventions were well tolerated with excellent compliance (96 ± 1% overall) by pill count and also supported by the expected rise in both serum n-3FA and n-3FA/Omega-6 fatty acids (n-6FA) ratio in women randomized to groups 4 and 5 (P<0.05). Lovaza decreased serum triglycerides and increased high-density lipoprotein (HDL) cholesterol compared with control (P<0.05 for both). Ral reduced serum IGF-1 in a dose-dependent manner (P<0.05) while Lovaza did not. Lovaza had no effect on IGF-1 or IGFBP-3. None of the other biomarkers were affected by our treatment.

conclusionThe combination of Lovaza and Ral is a feasible strategy that may be recommended in future breast cancer chemoprevention trials.

Indexed as

Feeding BehaviorAdultAgedBiomarkersBreast NeoplasmsC-Reactive ProteinDocosahexaenoic AcidsDose-Response Relationship, DrugDrug CombinationsEicosapentaenoic AcidEndpoint DeterminationEstrogen AntagonistsFatty Acids, Omega-3Feasibility StudiesFemaleHumansBiomarkersC-Reactive ProteinDocosahexaenoic AcidsDrug CombinationsEicosapentaenoic AcidEstrogen AntagonistsFatty Acids, Omega-3Insulin-Like Growth Factor Binding Protein 3Insulin-Like Growth Factor IOmacorRaloxifene HydrochlorideSelective Estrogen Receptor Modulators

Identifiers

PMID22669332
OpenAlexW2022858583

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.