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

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.

The Level of Distress From Fatigue Reported in the Final Two Months of Life by a Palliative Care Population: An Australian National Prospective, Consecutive Case Series.

CONTEXT: Fatigue is the most commonly reported symptom in life-limiting illnesses, although not much is known about the distress it causes patients as they approach death. OBJECTIVES: To map the trajectory of distress from fatigue reported by an Australian palliative care population in the last 60 days leading up to death. METHODS: A prospective, longitudinal, consecutive cohort study using national data from the Australian Palliative Care Outcomes Collaboration between July 1, 2013, and December 31, 2018. Patients were included if they had at least one measurement of fatigue on a 0-10 numerical rating scale in the 60 days before death. Descriptive statistics were used to analyse patients by diagnostic cohort and functional status. RESULTS: A total of 116,604 patients from 203 specialist palliative care services were analyzed, providing 501,104 data points. Distress from fatigue affected up to 80% of patients referred to palliative care, with the majority experiencing moderate or severe distress. Malignant and nonmalignant diagnoses were equally affected, with the neurological cohort showing the greatest variability. The degree of distress correlated with a patient's functional level; it worsened as a patient's function declined until a patient became bedbound when the reporting of distress reduced. CONCLUSIONS: Distress from fatigue is high in this cohort of patients. Interventions to reduce this distress need to be a research priority.

How Confident Are We at Assessing and Managing Fatigue in Palliative Care Patients? A Multicenter Survey Exploring the Current Attitudes of Palliative Care Professionals.

Background: Fatigue is a common and significant problem for palliative care (PC) patients, affecting up to 80% of patients. Health care professionals (HCPs) commonly underestimate its significance and lack the confidence in how to manage it, resulting in poor quality of life. It is currently not known how PC professionals manage fatigue in clinical practice or what the barriers to implementation are. Objective: To determine the current attitudes of HCPs toward fatigue management in patients with a life-limiting illness. Design/Setting: An electronic survey, created on REDCap, was distributed to all staff working directly with PC patients in both the community and inpatient setting within the Sydney Local Health District. The study duration was for four weeks (May 1-30, 2018). Results: Participants recognized that fatigue is common, but only 58.5% recognized that severe fatigue is more distressing than pain. A total of 77.2% of participants do not find fatigue an easy symptom to manage and less than half (46.9%) feel confident assessing and managing it. There was no consistent systematic approach to management although exercise, education, and pacing/energy conservation were recognized as important interventions. Themes identified as potential barriers to management included lack of resources, poor patient and staff understanding, and patient/disease factors. Conclusions: HCPs lack confidence in assessing fatigue and completing an individualized management plan; the approaches adopted are highly variable. This justifies the need for further education, as well as further research assessing the efficacy of a multimodal intervention and a guideline to assist in management.