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.

Matsuoka, H; Clark, K; Fazekas, B; Oyamada, S; Brown, L; Ishiki, H; Matsuda, Y; Hasuo, H; Ariyoshi, K; Lee, J; Le, B; Allcroft, P; Kochovska, S; Fujiwara, N; Miyaji, T; Lovell, M; Agar, M; Yamaguchi, T; Satomi, E; Iwase, S; Phillips, J; Koyama, A; Currow, DC

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.

Matsuoka, H Clark, K Fazekas, B Oyamada, S Brown, L

Ishiki, H Matsuda, Y Hasuo, H Ariyoshi, K Lee, J Le, B Allcroft, P Kochovska, S Fujiwara, N Miyaji, T Lovell, M

Agar, M

Yamaguchi, T Satomi, E Iwase, S Phillips, J

Koyama, A Currow, DC

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Publisher:: BMJ PUBLISHING GROUP
Publication Type:: Journal Article
Citation:: BMJ Open, 2022, 12, (2), pp. e050182
Issue Date:: 2022-02-07

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Field	Value	Language
dc.contributor.author	Matsuoka, H
dc.contributor.author	Clark, K
dc.contributor.author	Fazekas, B
dc.contributor.author	Oyamada, S
dc.contributor.author	Brown, L https://orcid.org/0000-0003-4892-5822
dc.contributor.author	Ishiki, H
dc.contributor.author	Matsuda, Y
dc.contributor.author	Hasuo, H
dc.contributor.author	Ariyoshi, K
dc.contributor.author	Lee, J
dc.contributor.author	Le, B
dc.contributor.author	Allcroft, P
dc.contributor.author	Kochovska, S
dc.contributor.author	Fujiwara, N
dc.contributor.author	Miyaji, T
dc.contributor.author	Lovell, M https://orcid.org/0000-0002-1407-2748
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.contributor.author	Yamaguchi, T
dc.contributor.author	Satomi, E
dc.contributor.author	Iwase, S
dc.contributor.author	Phillips, J https://orcid.org/0000-0002-3691-8230
dc.contributor.author	Koyama, A
dc.contributor.author	Currow, DC
dc.date.accessioned	2022-09-30T03:39:42Z
dc.date.available	2022-09-30T03:39:42Z
dc.date.issued	2022-02-07
dc.identifier.citation	BMJ Open, 2022, 12, (2), pp. e050182
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/162189
dc.description.abstract	INTRODUCTION: Management 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.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ PUBLISHING GROUP
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2021-050182
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1103 Clinical Sciences, 1117 Public Health and Health Services, 1199 Other Medical and Health Sciences
dc.subject.mesh	Adult
dc.subject.mesh	Analgesics, Opioid
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Clinical Trials, Phase III as Topic
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Duloxetine Hydrochloride
dc.subject.mesh	Humans
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Neoplasms
dc.subject.mesh	Neuralgia
dc.subject.mesh	Pregabalin
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Humans
dc.subject.mesh	Neoplasms
dc.subject.mesh	Neuralgia
dc.subject.mesh	Analgesics, Opioid
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Double-Blind Method
dc.subject.mesh	Adult
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Clinical Trials, Phase III as Topic
dc.subject.mesh	Pregabalin
dc.subject.mesh	Duloxetine Hydrochloride
dc.subject.mesh	Cancer Pain
dc.title	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.
dc.type	Journal Article
utslib.citation.volume	12
utslib.location.activity	England
utslib.for	1103 Clinical Sciences
utslib.for	1117 Public Health and Health Services
utslib.for	1199 Other Medical and Health Sciences
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Strength - CHT - Health Technologies
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
pubs.organisational-group	/University of Technology Sydney/Centre for Health Technologies (CHT)
utslib.copyright.status	open_access	*
dc.date.updated	2022-09-30T03:39:39Z
pubs.issue	2
pubs.publication-status	Published online
pubs.volume	12
utslib.citation.issue	2

Abstract:

INTRODUCTION: Management 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.

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