Evidence map›Paper›PMID 28652279›Full record

Trial reportThe oncologist2017

Pregabalin for the Prevention of Oxaliplatin-Induced Painful Neuropathy: A Randomized, Double-Blind Trial.

Daniel Ciampi de Andrade, Manoel Jacobsen Teixeira, Ricardo Galhardoni, Karine S L Ferreira, Paula Braz Mileno, Nathalia Scisci, Alexandra Zandonai, William G J Teixeira, Daniel F Saragiotto, Valquíria Silva and 26 more

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 3 pooled it
2.8field-weighted citation impact, top 8% 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

39 citing papers in PubMed, 3 syntheses or guidelines pooled it, 68 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Efficacy of transauricular vagus nerve stimulation for the treatment of chemotherapy-induced painful peripheral neuropathy: a randomized controlled exploratory study.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2024
    Trial
  5. Trial
  6. Article
  7. Review
  8. Oxaliplatin-induced peripheral neuropathy: from pathogenesis to treatment.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Article
  14. Pregabalin for chemotherapy-induced neuropathy: background and rationale for further study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Review
  15. Article
  16. Review
  17. Review
  18. Treatment strategy of oxaliplatin-induced peripheral neuropathy: a retrospective, nationwide study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  19. Article
  20. Soluble epoxide hydrolase inhibition alleviates chemotherapy induced neuropathic pain.Frontiers in pain research (Lausanne, Switzerland) · 2022
    Article
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

36 authors at 4 institutions in 2 countries.

Daniel Ciampi de AndradeCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil ciampi@usp.br.
Manoel Jacobsen TeixeiraCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Ricardo GalhardoniCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Karine S L FerreiraCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Paula Braz MilenoCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Nathalia ScisciCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Alexandra ZandonaiCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
William G J TeixeiraInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Daniel F SaragiottoInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Valquíria SilvaCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Irina RaicherCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Rubens Gisbert CuryCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Ricardo MacarencoInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Carlos Otto HeiseDepartamento de Neurologia, Universidade de Sao Paulo, Brazil.
Mario Wilson Iervolino BrottoDepartamento de Neurologia, Universidade de Sao Paulo, Brazil.
Alberto Andrade de MelloDepartamento de Neurologia, Universidade de Sao Paulo, Brazil.
Marcelo Zini MegaleDepartamento de Neurologia, Universidade de Sao Paulo, Brazil.
Luiz Henrique Curti DouradoCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Luciana Mendes BahiaCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Antonia Lilian RodriguesCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Daniella ParravanoCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Julia Tizue FukushimaInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Jean-Pascal LefaucheurClinical Neurophysiology Unit, Department of Physiology, Henri Mondor University Hospital, AP-HP, Créteil, France.
Didier BouhassiraINSERM U-987, Centre d'Evaluation et de Traitement de la Douleur, Hôpital Ambroise Paré, Boulogne, France.
Evandro SobrozaInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Rachel P RiechelmannInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Paulo M HoffInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
PreOx Workgroup
Fernanda Valério da SilvaCentro de Dor, Departamento de Neurologia, Universidade de Sao Paulo, Sao Paulo, Brazil.
Thais ChileLIM 23, Instituto de Psiquiatria, Universidade de Sao Paulo, Brazil.
Camila S DaleDepartamento de Anatomia, Instituto de Ciências Biomedicas, Universidade de Sao Paulo, Brazil.
Daniela NebuloniInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Luiz SennaInstituto do Cancer do Estado de São Paulo, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Helena BrentaniLIM 23, Instituto de Psiquiatria, Universidade de Sao Paulo, Brazil.
Rosana L PaganoLaboratory of Neuromodulation and Experimental Pain, Hospital Sírio Libanês, Brazil.
Ângela M de SouzaCentro de Dor, Instituto do Cancer do Estado de São Paulo, São Paulo, Brazil.
Universidade de São Paulo · BRInstituto do Câncer do Estado de São Paulo · BRInserm · FRUniversité Paris-Est Créteil · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedPregabalin is a medication that can decrease neuronal hyperexcitability, relieve neuropathic pain, and reach stable plasma levels after a titration period of only a few days.Its use during oxaliplatin infusions was not able to decrease the incidence of chronic, oxalipaltin-related neuropathic pain, compared with placebo.

backgroundPatients with colorectal cancer (CRC) receiving oxaliplatin (OXA) develop acute and chronic painful oxaliplatin-induced peripheral neuropathy (OXAIPN). Acute and chronic OXA-related neuropathies have different pathophysiological bases, but both lead to a common phenomenon: central sensitization (CS) of nociceptive neuronal networks, leading to increased sensitivity (hyperlgesia, allodynia) in the somatosensory system, the common ground of chronic neuropathic pain. Because CS is related to increased risk of painful OXAIPN, we hypothesized that preemptive use of the anti-hyperalgesic drug pregabaline (known to decrease CS) during OXA infusions would decrease the incidence of chronic OXAIPN.

methodsPain-free, chemotherapy-naïve CRC patients receiving at least one cycle of modified-FLOX [5-FU(500 mg/m

resultsOne hundred ninety-nine patients (57.0 ± 10.7 years old, 98 female, 101 male) were randomized. Data from 56 patients were not included in the analyses (as they did not receive at least one full cycle of modified FLOX). Data from 78 patients in the pregabalin group and 65 patients in the placebo group were retained for analyses. At the last visit, pain intensity in the pregabalin group was 1.03 (95% confidence interval [CI] = 0.79-1.26), and 0.85 (95% CI = 0.64-1.06) in the placebo group, which did not reach significance. Scores from the BPI, MPQ, DN-4, NPSI, and NCS and side-effect profiles and incidence of death did not differ between groups. Quality of life (QoL) score did not differ between groups (placebo = 76.9 ± 23.1, pregabalin group 79.4 ± 20.6). Mood scores were not significantly different between groups (placebo 9.7 [8.1-11.2]; pregabalin 6.8 [5.6-8.0]).

conclusionThe preemptive use of pregabalin during OXA infusions was safe, but did not decrease the incidence of chronic pain related to OXAIPN.

Indexed as

AnticonvulsantsDouble-Blind MethodFemaleHumansMaleMiddle AgedOrganoplatinum CompoundsOxaliplatinPainPeripheral Nervous System DiseasesPregabalinAnticonvulsantsOrganoplatinum CompoundsOxaliplatinPregabalin

Identifiers

PMID28652279
PMCPMC5634769
OpenAlexW2637410905

What OpenQuestion holds

Textmetadata
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.