Evidence map›Paper›PMID 29136387›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2018

Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202.

N Lynn Henry, Joseph M Unger, Anne F Schott, Louis Fehrenbacher, Patrick J Flynn, Debra M Prow, Carl W Sharer, Gary V Burton, Charles S Kuzma, Anna Moseley and 5 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 57 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 3 pooled it
4.1field-weighted citation impact, top 4% 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

57 citing papers in PubMed, 3 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. The effect of exercise on aromatase inhibitor-induced musculoskeletal symptoms in breast cancer survivors :a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Pooled it
  4. Trial
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  9. Genome-wide association study of aromatase inhibitor discontinuation due to musculoskeletal symptoms.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Trial
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  11. Trial
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  17. Article
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  20. Management of menopausal symptoms following treatment for hormone receptor positive breast cancer.The British journal of general practice : the journal of the Royal College of General Practitioners · 2025
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

N Lynn HenryN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Joseph M UngerN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Anne F SchottN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Louis FehrenbacherN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Patrick J FlynnN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Debra M ProwN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Carl W SharerN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Gary V BurtonN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Charles S KuzmaN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Anna MoseleyN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Danika L LewN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Michael J FischN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Carol M MoinpourN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Dawn L HershmanN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
James L WadeN. Lynn Henry and Anne F. Schott, University of Michigan, Ann Arbor, MI; N. Lynn Henry, University of Utah Huntsman Cancer Institute, Salt Lake City, UT; Joseph M. Unger, Anna Moseley, and Danika L. Lew, Southwest Oncology Group Statistical Center and Fred Hutchinson Cancer Research Center; Carol M. Moinpour, Fred Hutchinson Cancer Research Center, Seattle, WA; Louis Fehrenbacher, Kaiser Permanente National Cancer Institute Community Oncology Research Program, Oakland, CA; Patrick J. Flynn, Metro Minnesota Community Clinical Oncology Program/Minnesota Oncology, St Louis Park, MN; Debra M. Prow, William R. Bliss Cancer Center, Ames, IA; Carl W. Sharer, Phoenixville Cancer Center, Phoenixville, PA; Gary V. Burton, Louisiana State University Health Science Center-Shreveport, Shreveport, LA; Charles S. Kuzma, FirstHealth of the Carolinas, Pinehurst, NC; Michael J. Fisch, AIM Specialty Health, Chicago, IL; Dawn L. Hershman, Columbia University, New York, NY; and James L. Wade III, Heartland National Cancer Institute Community Oncology Research Program, Decatur, IL.
Huntsman Cancer Institute · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI NORMAN WOLMARK · 2014 to 2026
$206.8M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
NRG Oncology NCORP Research Base-BIQSFPUG1CA189867 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Deborah Watkins Bruner, Lisa A. Kachnic · 2014 to 2026
$140.5M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
SWOG NCORP Research BaseUG1CA189974 · NCI · THE HOPE FOUNDATION · PI CHARLES D. BLANKE, DAWN HERSHMAN · 2014 to 2026
$80.6M
Kaiser Permanente NCI National Community Oncology Research Program, NCORPUG1CA189821 · NCI · KAISER FOUNDATION RESEARCH INSTITUTE · PI Jennifer Marie Suga · 2014 to 2026
$44.4M
Heartland Cancer Research NCORPUG1CA189830 · NCI · DECATUR MEMORIAL HOSPITAL · PI Bryan A. Faller · 2014 to 2026
$40.9M
Southeast Clinical Oncology Research Consortium, Inc. (SCOR)UG1CA189858 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI Judith O Hopkins, William J Irvin · 2014 to 2026
$38.8M
Michigan Cancer Research Consortium NCORPUG1CA189971 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI Tareq Al baghdadi · 2014 to 2026
$36.6M
The Pacific Cancer Research Consortium (PCRC), an NCORP Community SiteUG1CA189953 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI Alison Katherine Conlin, Charles Drescher · 2014 to 2026
$27.4M
Gulf South Minority/Underserved Clinical Trials Network (Gulf South M/U CTN)UG1CA189854 · NCI · LSU HEALTH SCIENCES CENTER · PI AUGUSTO C. OCHOA · 2014 to 2026
$27.1M
The NCI Community Oncology Research Program: The New Mexico NCORPUG1CA189856 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Carolyn Y. Muller, Bernard Tawfik · 2014 to 2026
$20.6M
NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180818NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180835NCI NIH HHS U10 CA180868NCI NIH HHS U54 CA210962NCI NIH HHS U54 CA210963NCI NIH HHS UG1 CA189804NCI NIH HHS UG1 CA189808NCI NIH HHS UG1 CA189816NCI NIH HHS UG1 CA189821NCI NIH HHS UG1 CA189822NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA189829NCI NIH HHS UG1 CA189830NCI NIH HHS UG1 CA189848NCI NIH HHS UG1 CA189853NCI NIH HHS UG1 CA189854NCI NIH HHS UG1 CA189856NCI NIH HHS UG1 CA189858NCI NIH HHS UG1 CA189867NCI NIH HHS UG1 CA189872NCI NIH HHS UG1 CA189873NCI NIH HHS UG1 CA189952NCI NIH HHS UG1 CA189953NCI NIH HHS UG1 CA189954NCI NIH HHS UG1 CA189957NCI NIH HHS UG1 CA189960NCI NIH HHS UG1 CA189971NCI NIH HHS UG1 CA189972NCI NIH HHS UG1 CA189974NCI NIH HHS UG1 CA190002NCI NIH HHS UG1 CA233178
6 · The paper itself

Abstract

Purpose Adherence to aromatase inhibitor (AI) therapy for early-stage breast cancer is limited by AI-associated musculoskeletal symptoms (AIMSS). Duloxetine is US Food and Drug Administration approved for treatment of multiple chronic pain disorders. We hypothesized that treatment of AIMSS with duloxetine would improve average joint pain compared with placebo. Methods This randomized, double-blind, phase III trial included AI-treated postmenopausal women with early-stage breast cancer and who had average joint pain score of ≥ 4 out of 10 that developed or worsened since AI therapy initiation. Patients were randomly assigned 1:1 to duloxetine or placebo for 13 weeks. The primary end point was average joint pain through 12 weeks, examined using multivariable linear mixed models, adjusted for stratification factors (baseline pain score of 4 to 6 v 7 to 10 and prior taxane use). Clinically significant change in average pain was defined as a ≥ 2-point decrease from baseline. Results Of 299 enrolled patients, 127 patients treated with duloxetine and 128 who received placebo were evaluable for the primary analysis. By 12 weeks, the average joint pain score was 0.82 points lower for patients who received duloxetine compared with those who received placebo (95% CI, -1.24 to -0.40; P = .0002). Similar patterns were observed for worst joint pain, joint stiffness, pain interference, and functioning. Rates of adverse events of any grade were higher in the duloxetine-treated group (78% v 50%); rates of grade 3 adverse events were similar. Conclusion Results of treatment with duloxetine for AIMSS were superior to those of placebo among women with early-stage breast cancer, although it resulted in more frequent low-grade toxicities.

Indexed as

AdultAgedAged, 80 and overAnalgesicsAromatase InhibitorsArthralgiaBreast NeoplasmsDouble-Blind MethodDuloxetine HydrochlorideFemaleHumansMiddle AgedNeoplasm StagingPain MeasurementTime FactorsTreatment OutcomeAnalgesicsAromatase InhibitorsDuloxetine Hydrochloride

Identifiers

PMID29136387
PMCPMC5805479
OpenAlexW2768389306

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Read underepoch 390

Registered trials

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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.