Evidence map›Paper›PMID 25043153›Full record

Trial reportCancer2014

Phase III double-blind, placebo-controlled study of gabapentin for the prevention of delayed chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic chemotherapy, NCCTG N08C3 (Alliance).

Debra L Barton, Gita Thanarajasingam, Jeff A Sloan, Brent Diekmann, Jyotsna Fuloria, Lisa A Kottschade, Alan P Lyss, Anthony J Jaslowski, Miroslaw A Mazurczak, Scott C Blair and 2 more

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.

  1. Prevalence and predictors of long-delayed (> 120 h) chemotherapy-induced nausea and vomiting (CINV)-a systematic review and individual patient data meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023
    Pooled it
  2. Chemotherapy-induced nausea and vomiting: incidence and characteristics of persistent symptoms and future directions NCCTG N08C3 (Alliance).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
    Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Article
  8. Moxibustion for Chemotherapy-Induced Nausea and Vomiting: A Systematic Review and Meta-Analysis.Evidence-based complementary and alternative medicine : eCAM · 2017
    Review
  9. Newest Drugs for Chronic Unexplained Nausea and Vomiting.Current treatment options in gastroenterology · 2016
    Review
  10. Chemotherapy targeting cancer stem cells.American journal of cancer research · 2015
    Review
  11. 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

12 authors at 7 institutions in 1 country.

Debra L BartonMayo Clinic Rochester, Rochester, Minnesota.
Gita Thanarajasingam
Jeff A Sloan
Brent Diekmann
Jyotsna Fuloria
Lisa A Kottschade
Alan P Lyss
Anthony J Jaslowski
Miroslaw A Mazurczak
Scott C Blair
Shelby Terstriep
Charles L Loprinzi
Mayo Clinic · USColumbus Community Clinical Oncology Program · USFargo VA Health Care System · USHeartland Cancer Research · USMontana Cancer Consortium · USOchsner Medical Center · USRegional Cancer Center · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
Women's Cancer ProgramP30CA015083 · NCI · MAYO CLINIC ROCHESTER · PI Keith L. Knutson · 1985 to 2026
$151.3M
Collaborations and NCORP Collective ManagementUG1CA189823 · NCI · MAYO CLINIC ROCHESTER · PI Evanthia Galanis, Olwen Hahn · 2014 to 2026
$120.6M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
SIOUX COMMUNITY CANCER CONSORTIUMU10CA035103 · NCI · UNIVERSITY OF SOUTH DAKOTA · PI MAZURCZAK, MIROSLAW · 1985 to 2014
$11.6M
MISSOURI VALLEY CANCER CONSORTIUM CCOPU10CA063849 · NCI · MISSOURI VALLEY CANCER CONSORTIUM, INC. · PI SOORI, GAMINI · 1994 to 2014
$11.3M
NCI NIH HHS CA-25224NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35195NCI NIH HHS CA-35267NCI NIH HHS CA-35269NCI NIH HHS CA-35272NCI NIH HHS CA-35415NCI NIH HHS CA-37404NCI NIH HHS CA-37417NCI NIH HHS CA-63848NCI NIH HHS CA-63849NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035431NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035101NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035113NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035195NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035269NCI NIH HHS U10 CA035272NCI NIH HHS U10 CA035415NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA037417NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA063849NCI NIH HHS UG1 CA189823
6 · The paper itself

Abstract

backgroundDespite targeted antiemetics, data support an unmet need related to the management of delayed nausea and vomiting (NV). Promising pilot data informed this phase III trial evaluating gabapentin for delayed NV from highly emetogenic chemotherapy (HEC).

methodsParticipants were randomized to receive prophylactic treatment with 20 mg of dexamethasone and a 5HT3 receptor antagonist (RA) on the day of chemotherapy, followed by gabapentin 300 mg twice a day and dexamethasone (dex) or placebo and dex after HEC. Gabapentin/placebo was started the day of chemotherapy and continued through day 5 for the first chemotherapy cycle, whereas dex was titrated down on days 2-4. The primary end point was complete response (CR), defined as no emesis and no use of rescue medications on days 2-6, using an NV diary. The percentages of those in each group with a CR were compared by Fisher's exact test.

resultsFour hundred thirty patients were enrolled in this study. Forty-seven percent of patients in the gabapentin arm and 41% in the placebo arm had a CR (P = .23). Mean number of emesis episodes was <0.5 daily, and mean nausea severity was < 2 (mild). In both arms, patient satisfaction with NV control was greater than 8 (with 10 being perfectly satisfied). There were no significant differences in unwanted side effects.

conclusionsIn this study, gabapentin did not significantly improve delayed NV. Patients were satisfied with the control of their nausea and vomiting irrespective of arm. The use of a 5HT3 RA and dexamethasone provided good control of nausea and vomiting for most patients.

Indexed as

AdultAgedAminesAntineoplastic AgentsCyclohexanecarboxylic AcidsDouble-Blind MethodDrug Administration ScheduleFemaleGabapentingamma-Aminobutyric AcidHumansMaleMiddle AgedNauseaNeoplasmsPatient SatisfactionAminesAntineoplastic AgentsCyclohexanecarboxylic AcidsGabapentingamma-Aminobutyric Acidantiemetic therapydelayed nauseadelayed vomitinggabapentinrandomized controlled trial

Identifiers

PMID25043153
PMCPMC4221473
OpenAlexW1569030058

What OpenQuestion holds

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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.