Evidence map›Paper›PMID 42052361›Full record

ArticleJCO oncology advances2026

Alliance A221805: Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II Study.

Ellen M Lavoie Smith, Minji Lee, Mary R Scott, Heshan Liu, Shauna Hillman, Tracy Rieken, Rachel Wills, Julian Diaz-Cobo, Selina Chow, Heidi D Finnes and 12 more

Abstract read
In one paragraph

Article in JCO oncology advances, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Innate immunity in chemotherapy-induced peripheral neuropathy: recent advances.Frontiers in pain research (Lausanne, Switzerland) · 2025
    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

22 authors.

Ellen M Lavoie SmithUniversity of Alabama at Birmingham, Birmingham, AL.ORCID 0000-0002-6519-6636
Minji LeeAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.ORCID 0000-0002-1301-4319
Mary R ScottUniversity of Alabama at Birmingham, Birmingham, AL.ORCID 0009-0009-5330-8811
Heshan LiuAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
Shauna HillmanAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
Tracy RiekenAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.ORCID 0009-0007-5186-0122
Rachel WillsAlliance Protocol Operations Office, Chicago, IL.
Julian Diaz-CoboAlliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
Selina ChowAlliance Protocol Operations Office, Chicago, IL.
Heidi D FinnesMayo Clinic, Rochester, MN.ORCID 0000-0002-1117-0983
Kathryn RuddyMayo Clinic, Rochester, MN.ORCID 0000-0001-6298-332X
Jeffrey MeyerhardtDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0002-1120-0898
Eileen O'ReillyMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-8076-9199
Tareq Al BaghdadiTrinity Health Saint Joseph Mercy Hospital, Ann Arbor, MI.ORCID 0009-0004-4690-669X
Narjust FlorezDana-Farber/Harvard Cancer Center, Boston, MA.ORCID 0000-0002-7814-1773
Jordan KharofaUniversity of Cincinnati Cancer Center, Cincinnati, OH.
Rang GovindarajanUniversity of Arkansas for Medical Sciences, Little Rock, AR.ORCID 0000-0002-7278-1059
Mohamedtaki TejaniAdventHealth Orlando, Orlando, FL.
Ki ChungNCORP of the Carolinas (Prisma Health NCORP), Greenville, SC.
David ZahriehAlliance Statistics and Data Management Center, Rochester, MN.ORCID 0000-0003-0529-5146
Charles LoprinziMayo Clinic, Rochester, MN.ORCID 0000-0001-8044-5752
Maryam LustbergYale University, New Haven, CT.ORCID 0000-0001-8559-5645

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Quynh-Thu Xuan Le, ROBERT S. MANNEL · 2014 to 2026
$206.8M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
NCI, National Clinical Trials Network Lead Academic Participating Site (LAPS) UG1 (funded extension)UG1CA232760 · NCI · MAYO CLINIC ROCHESTER · PI Judy Caroline Boughey, Aaron Scott Mansfield · 2019 to 2026
$8.5M
Duloxetine to Prevent Oxaliplatin-Induced Chemotherapy-Induced Peripheral Neuropathy: A Randomized, Double-Blind, Placebo-Controlled Phase II to Phase III StudyR01CA235726 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI SMITH, ELLEN MARY LAVOIE · 2019 to 2024
$1.8M
NCI NIH HHS R01 CA235726NCI NIH HHS U10 CA180868NCI NIH HHS UG1 CA189823NCI NIH HHS UG1 CA232760
6 · The paper itself

Abstract

purposeThe primary objective of this randomized, double-blind, placebo-controlled, multicenter phase II study (Alliance A221805) was to screen two doses of duloxetine for preventing sensory oxaliplatin-induced peripheral neuropathy (OIPN).

methodsParticipants were randomly assigned 1:1:1 to receive once daily 30 mg duloxetine, 60 mg duloxetine, or placebo. Eligible participants had stage II to III colorectal cancer and no baseline neuropathy, had Eastern Cooperative Oncology Group performance status 0-2, were age 25 years and older, and received oxaliplatin via one of the following doses and schedules: 85 mg/m

resultsOf the 199 participants (n = 66, 30 mg duloxetine; n = 66, 60 mg duloxetine; n = 67, placebo), 46, 47, and 50 (N = 143, 71.8%), respectively, were evaluable for primary end point analysis based on modified intention-to-treat criteria. Participant mean age was 55.1 years (standard deviation = 10.4). Most were White (n = 113, 80.7%) and male (n = 82, 58.6%). The proportion of responders among those receiving placebo (68.0%) was similar to those receiving duloxetine 30 mg (65.2%) or 60 mg (66.0%). Duloxetine adherence rates, measured via pill counts-30 mg (54%), 60 mg (57%), and placebo (59%) groups-were low (<75%).

conclusionDuloxetine is not more promising than placebo for preventing sensory OIPN.

Identifiers

PMID42052361
PMCPMC13120771

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.