Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000747325
Ethics application status
Approved
Date submitted
18/05/2017
Date registered
22/05/2017
Date last updated
16/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Lidocaine (lignocaine) for Neuropathic Cancer Pain – Feasibility study (LiCPain)
Scientific title
A multi-centre double blind randomised controlled trial of continuous subcutaneous lidocaine (lignocaine) for the management of neuropathic cancer pain - a feasibility study.
Secondary ID [1] 291938 0
Nil known
Universal Trial Number (UTN)
Trial acronym
LiCPain
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuropathic Cancer Pain 303274 0
Condition category
Condition code
Cancer 302701 302701 0 0
Any cancer
Neurological 302805 302805 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lidocaine (lignocaine) hydrochloride 10%w/v (500mg/5ml) delivered via continuous subcutaneous infusion over 72 hours. Dose will be titrated from 1 to 2 mg/kg/hr with a maximum dose of 120mg/hour.

The continuous subcutaneous infusion of lidocaine (lignocaine)/placebo will commence on day 1 at T0 of the trial at 1mg/kg/hr (maximum 120mg/hr) .

The dose will be increased by 0.5mg/kg/hr every 24 hours to a maximum of 2mg/kg/hr or 120mg/hr (whichever is lower)
Unless
*If the patient’s average and worst pain score in the last 24 hours is 3/10, the dose will remain the same.
*If there are any new or increased toxicity these will be managed according to protocol. If the toxicity is not detailed, the study investigator will be informed and will make a clinical judgement which may include treatment of the symptom, dose reduction or cessation of infusion. If the assessing member is part of the clinical team, management will be guided by the study investigator or delegate.

After 72 hours (on day 4) the infusion will be ceased.

The infusion will be administered by nursing staff as an inpatient.
Intervention code [1] 298057 0
Treatment: Drugs
Comparator / control treatment
Sodium chloride 0.9% (NaCl 0.9%) delivered via continuous subcutaneous infusion over 72 hours.
Control group
Placebo

Outcomes
Primary outcome [1] 302100 0
The primary outcome is the completion rate of the study medication and procedures from day 1 to day 4. A completion rate of 80% or more of randomised patients is considered feasible and a completion rate of 60% or less is considered unacceptable.
Timepoint [1] 302100 0
Day 4
Secondary outcome [1] 334745 0
The number of eligible participants who are consented and randomised within the first eighteen months from the lead site opening.
Timepoint [1] 334745 0
18 months post lead site activation
Secondary outcome [2] 334746 0
Recruitment to screening ratio.
Timepoint [2] 334746 0
study recruitment completion
Secondary outcome [3] 334747 0
Completion of data; percentage of all data fields in case report form completed.
Timepoint [3] 334747 0
Day 4
Secondary outcome [4] 334748 0
Acceptability of subcutaneous lidocaine (lignocaine) or placebo infusion and study design to participants and carers as determined by semi-structured interview.
Timepoint [4] 334748 0
Day 4
Secondary outcome [5] 334749 0
Impacts of the intervention relevant to participants and carers as determined by semi-structured interview.
Timepoint [5] 334749 0
Day 4
Secondary outcome [6] 334750 0
Time taken to complete study measures at the assessment prior to dose change using the time recorded on the CRF by the study nurse.
Timepoint [6] 334750 0
24, 48 and 72 hours post commencement of study drug.
Secondary outcome [7] 334751 0
Time taken to complete quantitative sensory testing using the time recorded on the case report form by the investigator or study nurse.
Timepoint [7] 334751 0
Day 4
Secondary outcome [8] 334752 0
The proportion of participants who have an improvement from baseline to day 4 in worst pain of 1 point or more on the Brief Pain Inventory – short form (BPI-SF). (minimal clinically important difference)
Timepoint [8] 334752 0
Day 4
Secondary outcome [9] 334753 0
The proportion of participants who have an improvement from baseline to day 4 in average pain of 1 points or more on the BPI-SF
Timepoint [9] 334753 0
Day 4
Secondary outcome [10] 334754 0
The proportion of participants who have an improvement from baseline to day 4 in worst pain of 2 point or more on the BPI-SF (moderate clinically important difference)
Timepoint [10] 334754 0
Day 4
Secondary outcome [11] 334755 0
The proportion of participants who have an improvement from baseline to day 4 in average pain of 2 point or more on the BPI-SF
Timepoint [11] 334755 0
Day 4
Secondary outcome [12] 334756 0
The proportion of participants who have an improvement from baseline to day 4 in Worst pain of 4 points or more on the BPI-SF (major clinically important difference)
Timepoint [12] 334756 0
Day 4
Secondary outcome [13] 334757 0
The proportion of participants who have an improvement from baseline to day 4 in Average pain of 4 points or more on the BPI-SF
Timepoint [13] 334757 0
Day 4
Secondary outcome [14] 334758 0
The proportion of participants who have an improvement from baseline to day 4 in Worst pain to be reduced to less than or equal to 3 on the BPI-SF; and
The proportion of participants who have an improvement from baseline to day 4 in Average pain to be reduced to less than or equal to 3 on the BPI-SF.
Timepoint [14] 334758 0
Day 4
Secondary outcome [15] 334760 0
The proportion of participants who have an improvement from baseline to day 4 in Arithmetic mean of worst, least, average and now pain of 1 point or more on the BPI-SF
Timepoint [15] 334760 0
Day 4
Secondary outcome [16] 334761 0
The proportion of participants who have an improvement from baseline to day 4 in Number of breakthrough pain medications used as recorded by the study nurse from the electronic medical record.
Timepoint [16] 334761 0
Day 4
Secondary outcome [17] 334762 0
The proportion of participants who have an improvement from baseline to day 4 in Burning (superficial) spontaneous pain of 1 points or more on the Neuropathic pain symptom inventory (NPSI)
Timepoint [17] 334762 0
Day 4
Secondary outcome [18] 334763 0
The proportion of participants who have an improvement from baseline to day 4 in Pressing (deep) spontaneous pain of 1 points or more on the NPSI
Timepoint [18] 334763 0
Day 4
Secondary outcome [19] 334764 0
The proportion of participants who have an improvement from baseline to day 4 in Paroxysmal pain of 1 points or more on the NPSI
Timepoint [19] 334764 0
Day 4
Secondary outcome [20] 334765 0
The proportion of participants who have an improvement from baseline to day 4 in Evoked pain of 1 points or more on the NPSI
Timepoint [20] 334765 0
Day 4
Secondary outcome [21] 334766 0
The proportion of participants who have an improvement from baseline to day 4 in Parasthesia/Dysesthesia of 1 points or more on the NPSI
Timepoint [21] 334766 0
Day 4
Secondary outcome [22] 334767 0
The proportion of participants who have an improvement from baseline to day 4 in Pain intensity response of 1 point or more to brush testing in the painful area (sub-study)
Timepoint [22] 334767 0
Day 4
Secondary outcome [23] 334768 0
The proportion of participants who have an improvement from baseline to day 4 in Pain threshold for monofilament testing in the painful area (sub-study)
Timepoint [23] 334768 0
Day 4
Secondary outcome [24] 334769 0
The proportion of participants who have an improvement from baseline to day 4 in Pain intensity of 1 point or more to suprathreshold stimulus in the painful area (sub-study)
Timepoint [24] 334769 0
Day 4
Secondary outcome [25] 334770 0
Global impression of change measured on a 7 point scale
Timepoint [25] 334770 0
Day 4
Secondary outcome [26] 334771 0
Mean change in worst and average pain on BPI-SF
Timepoint [26] 334771 0
Day 4
Secondary outcome [27] 334773 0
Proportion of participants who achieve their personalized pain goal.

The personalized pain goal is a tool used to tailor pain management to individual needs. “Patients are asked to describe on a 0-10 scale, the level/intensity of pain that will allow the patient to achieve comfort in physical, functional, and psychosocial domains”
Timepoint [27] 334773 0
Day 4
Secondary outcome [28] 334774 0
Proportion of responders, defined as those who have at least a 1-point reduction in worst pain on BPI-SF on day 4 OR those who have unchanged pain but a reduction in number of breakthrough medications used in the last 24 hours as recorded by the study nurse.
Timepoint [28] 334774 0
Day 4
Secondary outcome [29] 334775 0
Proportion of responders, defined as those who have at least a 1-point reduction in worst pain on BPI-SF on day 4 AND breakthrough medication use which is unchanged or reduced in the last 24 hours as recorded by the study nurse.
Timepoint [29] 334775 0
Day 4
Secondary outcome [30] 334782 0
Cumulative responders for all changes in worst pain score on BPI-SF on day 4
Timepoint [30] 334782 0
Day 4
Secondary outcome [31] 334783 0
Cumulative responders for the proportion of participants who have a reduction in worst pain score of 1 point or more on day 2, 3 and 4 on an 11 point numeric rating scale.
Timepoint [31] 334783 0
Day 2, 3, 4
Secondary outcome [32] 334786 0
The proportion of responders, defined by a 1-point reduction in worst pain at day 4 on an 11 point numeric rating scale, who have a continued response at day 9, 15 and 29 will be calculated for each group.
Timepoint [32] 334786 0
Day 9, 15, 29
Secondary outcome [33] 334787 0
Prospectively sought adverse events with the likelihood of relationship to intervention. These will be assessed daily by the study nurse and graded according to the National Institutes of Health Common Terminology Criteria for Adverse Events. The investigator will assess the likely degree of causality according to www.niaid.nih.gov/ncn/sop/adverseevents.htm.
Timepoint [33] 334787 0
Day 29
Secondary outcome [34] 334788 0
The median dose at study completion
Timepoint [34] 334788 0
Day 4
Secondary outcome [35] 334789 0
The relationship between serum lidocaine (lignocaine) level at steady state and continuous subcutaneous infusion dose (sub-study) and Preliminary relationship between serum lidocaine (lignocaine) level and efficacy as measured by an improvement from baseline to day 4 in worst pain of 1 point or more on the Brief Pain Inventory – short form (BPI-SF) and toxicity as measured by the number of adverse effects.
Timepoint [35] 334789 0
Day 1, 2, 3, 4
Secondary outcome [36] 334790 0
Completion rate of EQ-5D-5L(generic)
Timepoint [36] 334790 0
Day 1, 4
Secondary outcome [37] 334791 0
Arithmetic mean of the seven items assessing interference on the BPI-SF on day 4 compared with baseline. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration
Timepoint [37] 334791 0
Day 4
Secondary outcome [38] 334792 0
Total RUG-ADL score on day 4 compared to baseline
Timepoint [38] 334792 0
Day 4
Secondary outcome [39] 334793 0
Cost of medication [lidocaine (lignocaine) and analgesic medication costs. This will be calculated from the medications entered on the case report form.
Timepoint [39] 334793 0
Discharge from hospital
Secondary outcome [40] 334794 0
Cost of management of adverse effects; inpatient stays excluding pharmacy costs. This will be calculated by the diagnosis related group codes entered by the study staff.
Timepoint [40] 334794 0
Day 4

Eligibility
Key inclusion criteria
*Age 18 years or more
*English speaking and able to read study questionnaires (5th grade level)
*Able to complete study assessments and complying with the study procedures
*Ability to provide informed written consent
*Participant is willing to be an inpatient for the duration of the trial
*Pain related to cancer or its treatment with an worst pain score of 4 or greater on an 11 point numerical rating scale in the past 24 hours
*Patient’s cancer may be solid tumour or haematological
*A score of 12 or greater on the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale
*An adequate trial of opioid medication defined as titration to the maximum tolerated dose as limited by adverse effects or titration to at least a dose of 60mg/day oral morphine equivalent, for at least 24 hours
or inability to tolerate opioids (eg due to allergy)
*An adequate trial of at least one adjuvant analgesic
or inability to tolerate any adjuvant analgesic listed in protocol (eg. due to comorbidity, medication interaction or previous adverse effects)
or inability to take oral medications (as determined by the treating clinician eg due to dysphagia)
or expected poor absorption of oral medications (as determined by the treating clinician, eg due to vomiting)
*Stable regular adjuvant analgesics, opioids, antidepressants, anticonvulsants, benzodiazepines, paracetamol, non-steroidal anti-inflammatory drugs and steroids for 24 hours. Transdermal opioids must have had stable dosing for 48 hours due to the extended time to reach steady state. Short acting breakthrough opioid may be used as required.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Previous adverse reaction to lidocaine (lignocaine) or other amide-type local anaesthetics such as prilocaine, mepivacaine or bupivacaine
*Use of systemic lidocaine (lignocaine) infusion for analgesia within the four weeks prior to study entry at a dose greater than or equal to 1mg/kg/hr intravenous or subcutaneous
*Liver failure (Child class B or C, likely due to hepatic impairment)
*Renal failure (eGFR <15ml/min/1.73m2 )
*Cardiac comorbidity deemed a contraindication by the treating clinician including
*cardiac failure (New York Heart Association class II or greater within the past year
*heart block (first, second or third degree) at any time in the past ten years
*Stokes-Adams syndrome
*Cardiac abnormalities at time of screening
*bradycardia less than 60 beats per minute at rest whilst awake
*systolic blood pressure less than 100mmHg or greater than 160mmHg sitting
*unstable angina or myocardial ischemia
*atrial or supraventricular tachycardia greater than 100 beats per minute at rest
*Seizure episode within the past 4 weeks
*Cognitive impairment (MoCA<26)
*Fluctuating level of consciousness or delirium as determined by the treating team
*Acute porphyria
*Current use of the following medications
*propranolol, phenytoin, amiodarone, metoprolol, nadolol, St John’s Wort, donepezil, cimetidine, flecainide, fluvoxamine
*dihydroergotamine, vernakalant, saquinavir, dronedarone, amprenavir, lopinavir, propofol, arbutamine, atazanavir, succinylcholine, dasabuvir, paritaprevir, cobicistat, hyaluronidase, delavirdine, fosamprenavir, etravirine, ombitasvir, quinidine, disopyramide, procainamide, tocainide, mexiletine, propafenone, encainide, moricizine, bupropion, telaprevir, penbutolol, rapacuronium, nevirapine, nitrous oxide, cisatracurium, indinavir, ritonavir
*Participants who have participated in a clinical study of a new chemical entity within the four weeks prior to study entry
*Pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer.
Pharmacy will be contacted whenever a person is under-going the screening process to warn them of a potential trial candidate. This will be followed up by a confirmatory call as soon as the person’s eligibility has been confirmed. The randomisation request will take the form of the prescription of the study drugs.

The REDCap randomisation tool will be used to facilitate randomisation. Random allocation tables will be created and uploaded into the REDCap project. Treatment for each participant will be allocated according to a block randomisation schedule in a 1:1 ratio. Block randomisation will ensure even allocation to each code. There will be no stratification at the randomisation level for this study.

Participants will be randomised when the pharmacist or delegate enter a participant’s REDCap record and click the “Randomize” button. Clicking this button triggers REDCap to check the allocation table and display the group to which the participant should be randomly assigned. This assignment is permanent and not editable within the participant record and, like all other activity within REDCap, is tracked and not modifiable in the audit log. The investigators, participants and statistician will be blinded.

The site clinical trials pharmacist will prepare the study drugs for the participant according to the allocation and label the vials.. Blinded vials will be dispensed to the ward for nursing staff to load into the syringe driver.

The allocation will be recorded on the schedule along with the date of allocation, the signature of the pharmacist preparing the vials and the patient ID number.

Participant randomisation will be registered with the coordinating site.

All medicine packs will be prepared by the site clinical trial pharmacist according to the randomisation schedule. Each pack of vials will be labelled according to the pre-determined allocation code and labeled as;

Lidocaine (lignocaine) for neuropathic cancer pain [032][LiCPain]. Participant ID [ID]
Lidocaine (lignocaine) 10%w/v (500mg/5ml) or placebo. Infuse 1-2mg/kg/hr (maximum 120mg/hr) as directed over 24 hours for 72 hours.

Treatment allocation will not be disclosed to study staff, treating clinicians or investigators. The code will only be broken in cases of extreme emergency. Such situations only include where knowledge of the code will have consequences for clinical decision making in consultation with the Lead Chief Investigator. Unblinding if required will be undertaken as per the PaCCSC standard operating procedure 4.7.2 Unblinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis
Based on an acceptable completion rate of 80% and an unacceptable completion rate of 60% the sample size is 36 patients.

The primary endpoint is feasibility, measured by the completion rate of study medication and procedures from day 1 to day 4.

1.1 Statistical analysis of feasibility primary outcome:
The study completion rate will be calculated by the number of participants in both arms who complete the study medication and procedures from day 1 to 4 as a percentage of the total number of participants randomised. A rate which has a confidence interval including 80% and excluding 60% will be considered feasible.

1.2 Statistical analysis of feasibility secondary outcomes
The number of eligible participants who are consented and randomised within the first eighteen months from the lead site opening will be documented. 36 patients is considered satisfactory. The time clock will be adjusted if the study requires a break for operational reasons. The number of patients randomised as a percentage of number of patients screened will be calculated. The data completion rate will be calculated. A rate of greater than 80% of patients with complete data set is considered satisfactory. The mean and range of time taken to complete study measures will be calculated for the major assessment point prior to dose adjustment.
1.3 Statistical analysis of efficacy outcomes
Efficacy data is preliminary only. The responder rate will be calculated by determining the proportion of participants with an improvement on day 4 of 1 point or more in worst pain on the BPI-SF. It will be expressed as a risk ratio with 95% confidence intervals and chi squared test performed to determine significance.

The following outcomes are considered exploratory only. The same calculation will be undertaken to determine the proportion of participants with an improvement in
- Average pain of 1 points or more on the BPI-SF
- Worst pain of 2 point or more on the BPI-SF (moderate clinically important difference)
- Average pain of 2 point or more on the BPI-SF
- Worst pain of 4 points or more on the BPI-SF (major clinically important difference)
- Average pain of 4 points or more on the BPI-SF
- Worst pain of 30% or more on the BPI-SF (moderate clinically important difference)
- Average pain of 30%or more on the BPI-SF
- Worst pain of 50% or more on the BPI-SF (major clinically important difference)
- Average pain of 50% or more on the BPI-SF
- Worst pain to be reduced to less than or equal to 3 on the BPI-SF
- Average pain to be reduced to less than or equal to 3 on the BPI-SF
- Arithmetic mean of “worst, least, average and now” pain of 1 point or more on the BPI-SF
- Number of breakthrough pain medications used
- Burning (superficial) spontaneous pain of 1 point or more on the Neuropathic pain symptom inventory (NPSI)
- Pressing (deep) spontaneous pain of 1 point or more on the NPSI
- Paroxysmal pain of 1 point or more on the NPSI
- Evoked pain of 1 point or more on the NPSI
- Parasthesia/Dysesthesia of 1 point or more on the NPSI

The proportion of participants in each category of global impression of change on day 4 will be compared between the two groups. The mean change worst and average pain on BPI-SF will be compared between the two groups and confidence interval will be calculated.
The proportion of participants who achieve their ersonalized pain goal on day 4 will be compared. The total number of breakthrough medications used during the last 24 hours will be compared. The total number of breakthrough medications used during the 72 hours on study will be compared.

The proportion of responders, defined as those who have at least a 1-point reduction in pain on day 4 OR those who have unchanged pain but a reduction in number of breakthrough medications used in the last 24 hours will be calculated and compared between the two groups. This reflects the possible benefits of lignocaine infusion in both improving analgesia and as an opioid sparing agent.

The proportion of responders, defined as those who have at least a 1-point reduction in pain on day 4 AND breakthrough medication use which is unchanged or reduced in the last 24 hours. This is in line with recommendations by the Food and Drug Administration (FDA).

A cumulative responder graph for all changes in worst pain score on BPI-SF on day 4 will be plotted. A cumulative responder graph for the proportion of participants who have a reduction in worst pain score of 1 point or more on day 2, 3 and 4 will be plotted.

For those participants who respond, defined by a 1-point reduction in worst pain at day 4, the proportion who have a continued response at day 9, 15 and 29 will be calculated for each group.

Subgroup analysis will be performed to evaluate the following for potential as biomarkers of response to lignocaine
1. patients who have never had an adjuvant therapy vs patients who have not been on the maximal doses listed in appendix.
2. patients who are on minimal, moderate and large doses of morphine (<60, 60-200, >200 mg/day)
3. patients who have severe pain (7/10) and moderate pain (4-6/10)
4. patients with allodynia

An additional analysis will be conducted utilizing data collected at the last timepoint where the participant was on the infusion. In most cases this will be day 4. Where the participant ceases the infusion early, this will be at infusion cessation. Where the participant has withdrawn or there is missing data, this will be the last available measurement.

For the quantitative sensory testing sub-study, the proportion of participants with a reduction in pain threshold to monofilament testing and pain intensity of at least 1 point in response to brush testing will be compared at baseline and after infusion for the two groups. The pain intensity response to suprathreshold stimulus will be compared by plotting the logarithmic relationship between pressure and pain intensity.

Missing day 4 data will be imputed where possible by carrying forward the last available measurement.

All efficacy analyses are preliminary only and will assist to understand and predict the impact of subcutaneous lignocaine infusion on neuropathic cancer pain and guide inclusion criteria, outcome measurement and analysis of the phase III study.
1.4 Statistical analysis of toxicity outcomes
The rate of adverse effects will be tabulated.
1.5 Statistical analysis of pathophysiology outcomes including Pharmacokinetic sub-study
The steady state plasma concentrations will be measured relative to the infusion rate administered to estimate systemic exposure and calculation individual estimates of clearance in study participants. The steady state plasma concentrations will be related to pharmacological response to assess lidocaine (lignocaine) pharmacodynamics.
The median dose at study completion in mg/kg/hr for participants in the active arm will be calculated.
1.6 Statistical analysis of other outcomes
Direct costs of treatments will be compared with net clinical benefits for the purpose of preliminary economic analysis. The arithmetic mean of the seven items assessing interference on the Brief Pain Inventory – Short Form will be calculated. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration. A difference of one point is considered clinically significant. Health services data will be reported descriptively. Total RUG-ADL score on day 4 will be compared to baseline.
1.7 Qualitative and carer analysis sub-study
Interviews will be analysed using thematic analysis. Interviews will be carried out until no new information is generated. The recorded interviews will be transcribed verbatim. Data analysis will be carried out using NVivo software. Constant comparison method will be used to generate themes and report appropriate findings

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8017 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 8018 0
Sacred Heart Hospice - Darlinghurst
Recruitment hospital [3] 8019 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 16000 0
2139 - Concord
Recruitment postcode(s) [2] 16001 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 16002 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 296446 0
Other Collaborative groups
Name [1] 296446 0
Palliative Care Clinical Studies Collaborative (PaCCSC)
Country [1] 296446 0
Australia
Funding source category [2] 296450 0
Other Collaborative groups
Name [2] 296450 0
Improving Palliative Care in Clinical Trials (ImPaCCT)
Country [2] 296450 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway
Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 295398 0
None
Name [1] 295398 0
Address [1] 295398 0
Country [1] 295398 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297675 0
Sydney Local Health District HREC - Concord Repatriation General Hospital
Ethics committee address [1] 297675 0
Hospital rd
Concord 2139 NSW
Ethics committee country [1] 297675 0
Australia
Date submitted for ethics approval [1] 297675 0
23/05/2017
Approval date [1] 297675 0
21/09/2017
Ethics approval number [1] 297675 0
HREC/17/CRGH/151 CH62/6/2017-098

Summary
Brief summary
The primary purpose of this trial is to evaluate the feasibility, efficacy and toxicity of continuous lignocaine for the treatment of neuropathic pain in cancer patients.

Who is it for?
You may be eligible to enroll in this trial if you are aged 18 or over, have been diagnosed with cancer (solid tumour or haematological) and have neuropathic pain related to the cancer or its treatment with a worst pain score of at least 4 out of 11 in the past 24 hours.

Study details
All participants enrolled in this trial will be randomly allocated (by chance) to receive either lignocaine or sham treatment with saline. Participants will receive the allocated treatment as a continuous subcutaneous injection for 72 hours. The participant must be admitted to hospital during this treatment. The dose may be altered at 24 and 48 hours if the participant still experiences moderate or worse pain and has no serious adverse effects.. All participants will have assessments daily for the three days of treatment and weekly by phone up to 29 days after the start of treatment. Assessments will include sensory testing to test pain levels, questionnaires and blood samples.

It is hoped that the findings of this trial will provide information to inform a larger trial on whether the administration of lignocaine/sham treatment, and the trial assessments are feasible, as well as providing some initial information on the efficacy and safety of this treatment for neuropathic pain in cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74778 0
Dr Jessica Lee
Address 74778 0
Concord Centre for Palliative Care
Hospital rd Concord NSW 2139
Country 74778 0
Australia
Phone 74778 0
+61297676799
Fax 74778 0
+61297678064
Email 74778 0
[email protected]
Contact person for public queries
Name 74779 0
Jesssica Lee
Address 74779 0
Concord Centre for Palliative Care
Hospital rd Concord NSW 2139
Country 74779 0
Australia
Phone 74779 0
+61297676799
Fax 74779 0
Email 74779 0
[email protected]
Contact person for scientific queries
Name 74780 0
Jessica Lee
Address 74780 0
Concord Centre for Palliative Care
Hospital rd Concord NSW 2139
Country 74780 0
Australia
Phone 74780 0
+61297676799
Fax 74780 0
Email 74780 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23525Study protocol  [email protected]
23526Ethical approval  [email protected]
23527Informed consent form  [email protected]

Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLidocaine for Neuropathic Cancer Pain (LiCPain): study protocol for a mixed-methods pilot study.2023https://dx.doi.org/10.1136/bmjopen-2022-066125
N.B. These documents automatically identified may not have been verified by the study sponsor.