Evidence map›Paper›PMID 24619793›Full record

Trial reportCancer2014

North Central Cancer Treatment Group/Alliance trial N08CA-the use of glutathione for prevention of paclitaxel/carboplatin-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled study.

Alexis D Leal, Rui Qin, Pamela J Atherton, Paul Haluska, Robert J Behrens, Charles H Tiber, Patanit Watanaboonyakhet, Matthias Weiss, Paul T Adams, Travis J Dockter and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized 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 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
4.9field-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

48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
  2. Taxane acute pain syndrome (TAPS) in patients receiving taxane-based chemotherapy for breast cancer-a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
    Pooled it
  3. Treatment of taxane acute pain syndrome (TAPS) in cancer patients receiving taxane-based chemotherapy-a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
    Pooled it
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  13. Review
  14. Targeting therapy-induced senescence as a novel strategy to combat chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    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

12 authors at 6 institutions in 1 country.

Alexis D LealDepartment of Internal Medicine, Mayo Clinic Rochester, Rochester, Minnesota.
Rui Qin
Pamela J Atherton
Paul Haluska
Robert J Behrens
Charles H Tiber
Patanit Watanaboonyakhet
Matthias Weiss
Paul T Adams
Travis J Dockter
Charles L Loprinzi
Alliance for Clinical Trials in Oncology
Mayo Clinic · USColumbia St. Mary's Hospital · USIowa Oncology Research Association · USMarshfield Clinic · USMichigan Cancer Research Consortium · USTrinity Health · 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 AKHILESH PANDEY · 1985 to 2026
$151.3M
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
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
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
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035195 · NCI · CARLE FOUNDATION HOSPITAL (URBANA, IL) · PI ROWLAND, KENDRITH MARTIN · 1985 to 2014
$11.3M
NCI NIH HHS CA-25,224NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS CA-35,090NCI NIH HHS CA-35,103NCI NIH HHS CA-35,195NCI NIH HHS CA-35,267NCI NIH HHS CA-35,269NCI NIH HHS CA-35,272NCI NIH HHS CA-35,431NCI NIH HHS CA-35,448NCI NIH HHS CA-37,404NCI NIH HHS CA-52,352NCI NIH HHS CA-63,844NCI NIH HHS CA-63,848NCI NIH HHS CA-63,849NCI NIH HHS K05 CA124477NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA063844NCI NIH HHS P30 CA015083NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035103NCI NIH HHS U10 CA035195NCI NIH HHS U10 CA035267NCI NIH HHS U10 CA035269NCI NIH HHS U10 CA035272NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA035448NCI NIH HHS U10 CA037404NCI NIH HHS U10 CA052352NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA063849
6 · The paper itself

Abstract

backgroundChemotherapy-induced peripheral neuropathy (CIPN) is a significant side effect of taxane and platinum-based chemotherapy. Several studies have supported the potential benefit of glutathione for the prevention of platinum-induced CIPN. The current trial was designed to determine whether glutathione would prevent CIPN as a result of carboplatin/paclitaxel therapy.

methodsIn total, 185 patients who received treatment with paclitaxel and carboplatin were accrued between December 4, 2009 and December 19, 2011. Patients were randomized to receive either placebo (n = 91) or 1.5 g/m(2) glutathione (n = 94) over 15 minutes immediately before chemotherapy. CIPN was assessed using the European Organization for Research and Treatment of Cancer Quality-of-Life (EORTC-QLQ) 20-item, CIPN-specific (CIPN20) sensory subscale and the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

resultsThere were no statistically significant differences between the 2 study arms with regard to: 1) peripheral neurotoxicity, as assessed using both the EORTC-QLQ-CIPN20 (P = .21) and the CTCAE scales (P = .449 for grade ≥2 neurotoxicity; P = .039 for time to development of grade ≥2 neuropathy, in favor of the placebo); 2) the degree of paclitaxel acute pain syndrome (P = .30 for patients who received paclitaxel every 3-4 weeks and P = .002, in favor of the placebo, for patients who received weekly paclitaxel); 3) the time to disease progression (P = .63); or 4) apparent toxicities. Subgroup analyses did not reveal any evidence of benefit in any particular subgroup.

conclusionsThe results from this study do not support the use of glutathione for the prevention of paclitaxel/carboplatin-induced CIPN.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarboplatinDouble-Blind MethodFemaleGlutathioneHumansMaleMiddle AgedNeoplasmsPaclitaxelPeripheral Nervous System DiseasesPlacebosCarboplatinGlutathionePaclitaxelPlaceboscarboplatinchemotherapy-induced peripheral neuropathyglutathionepaclitaxelprevention

Identifiers

PMID24619793
PMCPMC4047184
OpenAlexW1587762479

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.