Evidence map›Paper›PMID 35131817›Full record

ArticleBMJ open2022

Phase III, international, multicentre, double-blind, dose increment, parallel-arm, randomised controlled trial of duloxetine versus pregabalin for opioid-unresponsive neuropathic cancer pain: a JORTC-PAL16 trial protocol.

Hiromichi Matsuoka, Katherine Clark, Belinda Fazekas, Shunsuke Oyamada, Linda Brown, Hiroto Ishiki, Yoshinobu Matsuda, Hideaki Hasuo, Keisuke Ariyoshi, Jessica Lee and 13 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 18% 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

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Mechanisms and multimodal treatment of neuropathic pain associated with degenerative cervical spondylosis: Current status and progress.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  3. 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

23 authors at 12 institutions in 4 countries.

Hiromichi MatsuokaDepartment of Psycho-Oncology, Supportive and Palliative Care Development Center, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan hiromima@ncc.go.jp.ORCID 0000-0002-7276-1971
Katherine ClarkIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Belinda FazekasIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Shunsuke OyamadaDepartment of Biostatistics, Japanese Organisation for Research and Treatment of Cancer (JORTC) Data Center, Arakawa-ku, Tokyo, Japan.
Linda BrownIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Hiroto IshikiDepartment of Palliative Medicine, National Cancer Center Hospital, Chuoh-ku, Tokyo, Japan.
Yoshinobu MatsudaDepartment of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan.ORCID 0000-0001-5092-9377
Hideaki HasuoDepartment of Psychosomatic Medicine, Kansai Medical University Hospital, Hirakata, Osaka, Japan.ORCID 0000-0002-4689-1203
Keisuke AriyoshiDepartment of Data Management, Japanese Organisation for Research and Treatment of Cancer (JORTC) Data Center, Arakawa-ku, Tokyo, Japan.
Jessica LeeIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Brian LeRoyal Melbourne Hospital, Melbourne, Victoria, Australia.
Peter AllcroftCollege of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
Slavica KochovskaIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Noriko FujiwaraDepartment of Palliative Medicine and Advanced Clinical Oncology, IMSUT Hospital of the Institute of Medical Science,The University of Tokyo, Japan, Tokyo, Japan.
Tempei MiyajiDepartment of Clinical Trial Data Management, Graduate School of Medicine, University of Tokyo, Bunkyo-ku, Tokyo, Japan.
Melanie LovellPalliative Care, Greenwich Hospital, Greenwich, New South Wales, Australia.
Meera AgarIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.
Eriko SatomiDepartment of Palliative Medicine, National Cancer Center Hospital, Chuoh-ku, Tokyo, Japan.
Satoru IwaseDepartment of Palliative Medicine, Saitama Medical University, Moroyama, Japan.
Jane PhillipsIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.
Atsuko KoyamaDepartment of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osakasayama, Osaka, Japan.
David C CurrowIMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), Faculty of Health, University of Technology Sydney, Sydney, New South Wales, Australia.ORCID 0000-0003-1988-1250
University of Technology Sydney · AUNational Cancer Center · USData Management (Italy) · ITFlinders University · AUGreenwich Hospital · USKansai Medical University · JPKindai University · JPNHO Kinki Chuo Chest Medical Center · JPSaitama Medical University · JPThe Royal Melbourne Hospital · AUTohoku University · JPUniversity of Tokyo Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionManagement of neuropathic cancer pain (NCP) refractory to regular opioids remains an important challenge. The efficacy of pregabalin for NCP except chemotherapy-induced peripheral neuropathy (CIPN) has already been confirmed in two randomised controlled trials (RCTs) compared with placebo. Duloxetine offers the potential of analgesia in opioid refractory NCP. However, there are no RCT of duloxetine for the management of opioid-refractory NCP as a first line treatment. Both classes of drugs have the potential to reduce NCP, but there has been no head-to-head comparison for the efficacy and safety, especially given differing side effect profiles. METHODS AND ANALYSIS: An international, multicentre, double-blind, dose increment, parallel-arm, RCT is planned. Inclusion criteria include: adults with cancer experiencing NCP refractory to opioids; Brief Pain Inventory (BPI)-item 3 (worst pain) of ≥4; Neuropathic Pain on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale of ≥12 despite of an adequate trial of regular opioid medication (≥60 mg/day oral morphine equivalent dose). Patients with CIPN are excluded.The study will recruit from palliative care teams (both inpatients and outpatients) in Japan and Australia. Participants will be randomised (1:1 allocation ratio) to duloxetine or pregabalin arm. Dose escalation is until day 14 and from day 14 to 21 is a dose de-escalation period to avoid withdrawal effects. The primary endpoint is defined as the mean difference in BPI item 3 for worst pain intensity over the previous 24 hours at day 14 between groups. A sample size of 160 patients will be enrolled between February 2020 and March 2023. ETHICS AND DISSEMINATION: Ethics approval was obtained at Osaka City University Hospital Certified Review Board and South Western Sydney Local Health District Human Research Ethics Committee. The results of this study will be submitted for publication in international journals and the key findings presented at international conferences. TRIAL REGISTRATION NUMBERS: jRCTs051190097, ACTRN12620000656932.

Indexed as

Cancer PainNeoplasmsNeuralgiaAdultAnalgesics, OpioidClinical Trials, Phase III as TopicDouble-Blind MethodDuloxetine HydrochlorideHumansMulticenter Studies as TopicPregabalinRandomized Controlled Trials as TopicTreatment OutcomeAnalgesics, OpioidDuloxetine HydrochloridePregabalinadult palliative carecancer painclinical trials

Identifiers

PMID35131817
PMCPMC8823224
OpenAlexW4210855545

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.