Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study.

Lee, J; Currow, D; Lovell, M; Phillips, JL; McLachlan, A; Ritchie, M; Brown, L; Fazekas, B; Aggarwal, R; Seah, D; Sheehan, C; Chye, R; Noble, B; McCaffrey, N; Aggarwal, G; George, R; Kow, M; Ayoub, C; Linton, A; Sanderson, C; Mittal, D; Rao, A; Prael, G; Urban, K; Vandersman, P; Agar, M

Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study.

Lee, J Currow, D

Lovell, M

Phillips, JL McLachlan, A Ritchie, M Brown, L

Fazekas, B Aggarwal, R Seah, D Sheehan, C Chye, R Noble, B McCaffrey, N Aggarwal, G George, R Kow, M Ayoub, C Linton, A Sanderson, C Mittal, D Rao, A Prael, G Urban, K Vandersman, P Agar, M

Permalink

Publisher:: BMJ
Publication Type:: Journal Article
Citation:: BMJ Open, 2023, 13, (2), pp. e066125
Issue Date:: 2023-02-21

Open Access

Copyright Clearance Process

Recently Added
In Progress
Open Access

This item is open access.

Download Published versionAdobe PDF (1.29 MB)

View on publisher's site

View statistics

Full metadata record

Field	Value	Language
dc.contributor.author	Lee, J
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250
dc.contributor.author	Lovell, M https://orcid.org/0000-0002-1407-2748
dc.contributor.author	Phillips, JL
dc.contributor.author	McLachlan, A
dc.contributor.author	Ritchie, M
dc.contributor.author	Brown, L https://orcid.org/0000-0003-4892-5822
dc.contributor.author	Fazekas, B
dc.contributor.author	Aggarwal, R
dc.contributor.author	Seah, D
dc.contributor.author	Sheehan, C
dc.contributor.author	Chye, R
dc.contributor.author	Noble, B
dc.contributor.author	McCaffrey, N
dc.contributor.author	Aggarwal, G
dc.contributor.author	George, R
dc.contributor.author	Kow, M
dc.contributor.author	Ayoub, C
dc.contributor.author	Linton, A
dc.contributor.author	Sanderson, C
dc.contributor.author	Mittal, D
dc.contributor.author	Rao, A
dc.contributor.author	Prael, G
dc.contributor.author	Urban, K
dc.contributor.author	Vandersman, P
dc.contributor.author	Agar, M https://orcid.org/0000-0002-6756-6119
dc.date.accessioned	2023-09-05T04:46:08Z
dc.date.available	2023-09-05T04:46:08Z
dc.date.issued	2023-02-21
dc.identifier.citation	BMJ Open, 2023, 13, (2), pp. e066125
dc.identifier.issn	2044-6055
dc.identifier.issn	2044-6055
dc.identifier.uri	http://hdl.handle.net/10453/171917
dc.description.abstract	INTRODUCTION: Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design. METHODS AND ANALYSIS: A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients' and carers' experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients' acceptability of the methodology, as well as providing a signal of whether this area should be further investigated. ETHICS AND DISSEMINATION: Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820. TRIAL REGISTRATION NUMBER: ANZCTR ACTRN12617000747325.
dc.format	Electronic
dc.language	eng
dc.publisher	BMJ
dc.relation.ispartof	BMJ Open
dc.relation.isbasedon	10.1136/bmjopen-2022-066125
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.classification	32 Biomedical and clinical sciences
dc.subject.classification	42 Health sciences
dc.subject.classification	52 Psychology
dc.subject.mesh	Humans
dc.subject.mesh	Lidocaine
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Neuralgia
dc.subject.mesh	Neoplasms
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Clinical Trials, Phase II as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Neoplasms
dc.subject.mesh	Neuralgia
dc.subject.mesh	Lidocaine
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Clinical Trials, Phase II as Topic
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Humans
dc.subject.mesh	Lidocaine
dc.subject.mesh	Pilot Projects
dc.subject.mesh	Cancer Pain
dc.subject.mesh	Treatment Outcome
dc.subject.mesh	Neuralgia
dc.subject.mesh	Neoplasms
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Clinical Trials, Phase II as Topic
dc.title	Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study.
dc.type	Journal Article
utslib.citation.volume	13
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	2023-09-05T04:46:07Z
pubs.issue	2
pubs.publication-status	Published online
pubs.volume	13
utslib.citation.issue	2

Abstract:

INTRODUCTION: Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design. METHODS AND ANALYSIS: A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients' and carers' experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients' acceptability of the methodology, as well as providing a signal of whether this area should be further investigated. ETHICS AND DISSEMINATION: Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820. TRIAL REGISTRATION NUMBER: ANZCTR ACTRN12617000747325.

Please use this identifier to cite or link to this item:

http://hdl.handle.net/10453/171917