Evidence map›Paper›PMID 29101597›Full record

Trial reportBreast cancer research and treatment2018

Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain.

Maryam B Lustberg, Tonya S Orchard, Raquel Reinbolt, Rebecca Andridge, Xueliang Pan, Martha Belury, Rachel Cole, Amanda Logan, Rachel Layman, Bhuvaneswari Ramaswamy and 6 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 6 pooled it
1.8field-weighted citation impact, top 14% 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

22 citing papers in PubMed, 6 syntheses or guidelines pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Review
  18. Review
  19. Article
  20. Article
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 at 2 institutions in 1 country.

Maryam B LustbergStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA. maryam.lustberg@osumc.edu.
Tonya S OrchardHuman Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, OH, USA.
Raquel ReinboltStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Rebecca AndridgeDivision of Biostatistics, College of Public Health, The Ohio State University, Columbus, OH, USA.
Xueliang PanThe Ohio State University Center for Biostatistics, Columbus, OH, USA.
Martha BeluryHuman Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, OH, USA.
Rachel ColeHuman Nutrition Program, Department of Human Sciences, The Ohio State University, Columbus, OH, USA.
Amanda LoganStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Rachel LaymanStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Bhuvaneswari RamaswamyStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Robert WesolowskiStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Michael BergerStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Elaine PattersonStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Charles LoprinziMayo Clinic Cancer Center, Mayo Clinic, Rochester, MN, USA.
Charles L ShapiroStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
Lisa YeeStefanie Spielman Comprehensive Breast Center, The Ohio State University, Columbus, OH, USA.
The Ohio State University · USMayo Clinic in Arizona · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
NCI NIH HHS P30 CA016058NCI NIH HHS UG1 CA189823
6 · The paper itself

Abstract

purposeAromatase inhibitor (AI)-induced joint symptoms negatively impact drug adherence and quality of life in breast cancer survivors. Mechanisms underlying symptoms may include inflammation. It is hypothesized that n - 3 polyunsaturated fatty acids (PUFAs) have anti-inflammatory properties and may reduce symptoms.

methodsWe conducted a randomized, double-blind, placebo-controlled study comparing 4.3 g/day n - 3 PUFA supplements vs placebo for 24 weeks in postmenopausal breast cancer patients starting adjuvant AIs. Primary endpoints were adherence and tolerability; secondary outcomes included inflammatory cytokines and symptoms assessed by the Brief Pain Inventory short form (BPI-SF) and Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) at 0, 12, and 24 weeks.

resultsForty-four women were randomized, of which 35 completed the study. Adherence was ≥ 88% based on these 35 patients with pill counts as well as change in red blood cell (RBC) n - 3 PUFAs. Common toxicities included grade 1 flatulence (55% of both groups) and belching (45% of n - 3 group). Mean pain severity scores (BPI-SF) did not change significantly by time or treatment arm. Quality of life, based on FACT-ES scores, significantly decreased within placebo (p = 0.04), but not the n - 3 group (p = 0.58), with a trend toward between-group differences (p = 0.06) at 12 weeks, but no significant differences at 24 weeks. RBC n - 3 levels were strongly positively correlated with FACT-ES at 12 weeks, but attenuated at 24 weeks.

conclusionHigh-dose n - 3 PUFA supplementation is feasible and well tolerated when administered with AIs. Additional studies are needed to evaluate efficacy in prevention of joint symptoms.

Indexed as

AdultAgedAromatase InhibitorsBreast NeoplasmsCancer SurvivorsDietary SupplementsDouble-Blind MethodFatty Acids, Omega-3FemaleHumansMiddle AgedMusculoskeletal PainNeoplasm StagingPilot ProjectsQuality of LifeSurveys and QuestionnairesAromatase InhibitorsFatty Acids, Omega-3Aromatase inhibitorsArthralgiasBreast cancer survivorsJoint symptomsOmega-3 fatty acids

Identifiers

PMID29101597
PMCPMC5809189
OpenAlexW2766174724

What OpenQuestion holds

Textmetadata
LicenceTDM
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.