Evidence map›Paper›PMID 26768436›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance).

Lisa Kottschade, Paul Novotny, Alan Lyss, Miroslaw Mazurczak, Charles Loprinzi, Debra Barton

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03996863 (PUCE Study), which is not on this map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 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.

NCT03996863 nawithdrawnnot on this mapstarted 2019, after this paper: background citation

PUCE Study: Prevention of Unmitigated Chemotherapy-induced Emesis

TypeinterventionalSponsorOtolith LabsRan2019 to 2019Enrolled0ConditionsChemotherapy-induced Nausea and Vomiting, Nausea Post ChemotherapyArmsOtoband, Placebo device
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it.

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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

6 authors.

Lisa KottschadeMayo Clinic, Rochester, MN, USA.
Paul NovotnyAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
Alan LyssHeartland Cancer Research CCOP, Missouri Baptist Medical Center, Saint Louis, MO, USA.
Miroslaw MazurczakSanford NCI Community Oncology Research Program, Sioux Falls, SD, USA.
Charles LoprinziMayo Clinic, Rochester, MN, USA.
Debra BartonSchool of Nursing, University of Michigan, 400 N. Ingalls, Suite 2153, Ann Arbor, MI, 48109, USA. debbartn@med.umich.edu.

Funding

Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA180867NCI NIH HHS UG1 CA189823
6 · The paper itself

Abstract

backgroundDespite newer agents, chemotherapy-induced nausea and vomiting (CINV) continues to remain a distressing side effect to a proportion of patients undergoing systemic anti-cancer therapy.

methodsWe recently performed an unplanned secondary analysis on a previously reported negative phase III trial (N08C3) looking at the efficacy of gabapentin/placebo in combination with dexamethasone and a 5HT3 receptor antagonist in the prevention of CINV for 413 patients undergoing regimens with highly emetogenic chemotherapy (HEC). In the current study, we attempted to better understand the higher than expected rate of overall patient satisfaction, despite a low complete response rate in both arms. Additionally, we looked at patient variables and their relationship to rates of CINV.

resultsApproximately one third of patients experienced more than mild nausea and reported scores on the Functional Living Index-Emesis that indicated interference with activities. Thirty-five percent reported nausea greater than 2.5 on a scale of 0 to 10 (0 being none), 19 % reported at least one emetic episode, and 49 % reported taking rescue medication. Nausea and vomiting on day 1, cisplatin therapy, and history of motion sickness significantly predicted delayed CINV. Age, combination chemotherapy (HEC with moderately emetogenic), and getting treatment for breast cancer predicted CINV on day 1. DISCUSSION: These data confirm previous reports that subgroups of patients may be more prone to acute and delayed CINV. Future CINV study design may benefit from a more individualized approach to CINV management, targeting those patients who are truly at risk for CINV despite continued drug development efforts.

Indexed as

AdultAgedAminesAntiemeticsAntineoplastic AgentsCisplatinCyclohexanecarboxylic AcidsDrug-Related Side Effects and Adverse ReactionsExcitatory Amino Acid AntagonistsFemaleGabapentingamma-Aminobutyric AcidHumansIncidenceMaleMiddle AgedAminesAntiemeticsAntineoplastic AgentsCisplatinCyclohexanecarboxylic AcidsExcitatory Amino Acid AntagonistsGabapentingamma-Aminobutyric AcidCharacteristicsChemotherapy-induced nausea and vomitingDelayed nausea and vomitingIncidenceOncology

Identifiers

PMID26768436
PMCPMC4984535

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Registered trials

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.