Evidence map›Paper›PMID 24531792›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2014

A phase III randomized, placebo-controlled study of topical amitriptyline and ketamine for chemotherapy-induced peripheral neuropathy (CIPN): a University of Rochester CCOP study of 462 cancer survivors.

Jennifer S Gewandter, Supriya G Mohile, Charles E Heckler, Julie L Ryan, Jeffrey J Kirshner, Patrick J Flynn, Judith O Hopkins, Gary R Morrow

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

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 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

59 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. BeyondFrontiers in pain research (Lausanne, Switzerland) · 2025
    Pooled it
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  12. Chemotherapy-induced peripheral neuropathy in breast cancer: a narrative review.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2026
    Review
  13. Chronic Pain in the Cancer Survivor.Current pain and headache reports · 2025
    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

8 authors.

Jennifer S GewandterDepartment of Anesthesiology, University of Rochester Medical Center, 601 Elmwood Ave, Box 604, Rochester, NY, 14642, USA, jennifer_gewandter@urmc.rochester.edu.
Supriya G Mohile
Charles E Heckler
Julie L Ryan
Jeffrey J Kirshner
Patrick J Flynn
Judith O Hopkins
Gary R Morrow

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
UNIVERSITY OF ROCHESTER--CCOP RESEARCH BASEU10CA037420 · NCI · UNIVERSITY OF ROCHESTER · PI MORROW, GARY R · 1985 to 2014
$21.1M
Cancer Control Research Training Curriculum (R25T)R25CA102618 · NCI · UNIVERSITY OF ROCHESTER · PI JANELSINS, MICHELLE C, MORROW, GARY R · 2004 to 2018
$6.7M
NCI NIH HHS R25 CA102618NCI NIH HHS U10 CA037420NCI NIH HHS U10CA37420NCI NIH HHS UG1 CA189961
6 · The paper itself

Abstract

purposeChemotherapy-induced peripheral neuropathy (CIPN) occurs in as high as 70% of patients receiving certain types of chemotherapy agents. The FDA has yet to approve a therapy for CIPN. The aim of this multicenter, phase III, randomized, double-blind, placebo-controlled trial was to investigate the efficacy of 2% ketamine plus 4% amitriptyline (KA) cream for reducing CIPN.

methodsCancer survivors who completed chemotherapy at least 1 month prior and had CIPN (>4 out of 10) were enrolled (N=462). CIPN was assessed using average scores from a 7-day daily diary that asks patients to rate the average "pain, numbness, or tingling in [their] hands and feet over the past 24 h" on an 11-point numeric rating scale at baseline and 6 weeks post intervention. ANCOVA was used to measure differences in 6-week CIPN with effects including baseline CIPN, KA treatment arm, and previous taxane therapy (Y/N).

resultsThe KA treatment showed no effect on 6-week CIPN scores (adjusted mean difference=-0.17, p=0.363).

conclusionsThis study suggests that KA cream does not decrease CIPN symptoms in cancer survivors.

Indexed as

Administration, TopicalAdultAgedAmitriptylineAntineoplastic AgentsDouble-Blind MethodFemaleHumansKetamineMaleMiddle AgedNeoplasmsNeurotoxicity SyndromesPeripheral Nervous System DiseasesTaxoidsUnited StatesAmitriptylineAntineoplastic AgentsKetamineTaxoids

Identifiers

PMID24531792
PMCPMC4040331

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.