Lidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study
Jessica Lee,
Beverly Noble,
Richard Chye,
Melanie Lovell,
Linda Brown,
Belinda Fazekas,
Meera Agar,
David Currow,
Rajesh Aggarwal,
Andrew McLachlan,
Davinia Seah,
Nikki McCaffrey,
Christine Sanderson,
Jane L Phillips,
Angela Rao,
Caitlin Sheehan,
Grace Prael,
Rachel George,
Megan Ritchie,
Ghauri Aggarwal,
Marian Kow,
Chadi Ayoub,
Anthony Linton,
Dipti Mittal,
Katalin Urban,
Priyanka Vandersman
Affiliations
Jessica Lee
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Beverly Noble
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Richard Chye
Palliative Care, St Vincent`s Health Australia Ltd, Sydney, New South Wales, Australia
Melanie Lovell
Greenwich Palliative and Supportive Care Services, HammondCare, Sydney, New South Wales, Australia
Linda Brown
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Belinda Fazekas
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Meera Agar
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
David Currow
University of Wollongong Faculty of Science Medicine and Health, Wollongong, New South Wales, Australia
Rajesh Aggarwal
Palliative Care, Bankstown Hospital, Bankstown, New South Wales, Australia
Andrew McLachlan
Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia
Davinia Seah
Palliative Care, St Vincent`s Health Australia Ltd, Sydney, New South Wales, Australia
Nikki McCaffrey
Deakin Health Economics, Deakin University School of Health and Social Development, Burwood, Victoria, Australia
Christine Sanderson
Territory Palliative Care, Alice Springs, Northern Territory, Australia
Jane L Phillips
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Angela Rao
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Caitlin Sheehan
Palliative Care, Calvary Health Care, Kogarah, New South Wales, Australia
Grace Prael
IMPACCT (Improving Palliative, Aged and Chronic Care through Clinical Research and Translation), University of Technology Sydney Faculty of Health, Broadway, New South Wales, Australia
Rachel George
Pharmacy, Concord Repatriation General Hospital, Concord, New South Wales, Australia
Megan Ritchie
Concord Centre for Palliative Care, Concord Repatriation General Hospital, Concord, New South Wales, Australia
Ghauri Aggarwal
Concord Centre for Palliative Care, Concord Repatriation General Hospital, Concord, New South Wales, Australia
Marian Kow
Pharmacy, Concord Repatriation General Hospital, Concord, New South Wales, Australia
Chadi Ayoub
Cardiology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA
Anthony Linton
Concord Cancer Centre, Concord Repatriation General Hospital, Concord, New South Wales, Australia
Dipti Mittal
Concord Centre for Palliative Care, Concord Repatriation General Hospital, Concord, New South Wales, Australia
Katalin Urban
Palliative Care, Northern New South Wales Local Health Network, Lismore, New South Wales, Australia
Priyanka Vandersman
Research Centre for Palliative Care Death & Dying, Flinders University, Adelaide, South Australia, Australia
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.
