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Subcutaneous Lidocaine For Cancer-Related Pain

Primary Purpose

Cancer-related Pain

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Lidocaine

Placebo (D5W)

About this trial

This is an interventional supportive care trial for Cancer-related Pain focused on measuring Pain, Cancer, Lidocaine, Sodium Channel Blockers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients 18 years of age or older
In or outpatients referred to the BCCA PSMPC Clinics with a diagnosis of cancer
Subjects must have somatic, visceral or neuropathic pain related to cancer
Pain intensity, measured by a worst pain score over the last 72 hours of ≥4 on a 0-10 numerical rating scale
Must have tried at least one opioid medication without adequate response or with significant side-effects for at least one week
For those with neuropathic pain, must have also tried at least one adjuvant analgesic, such as a tricyclic (unless contraindicated) or an anticonvulsant without adequate response or with significant side-effects for at least one week
Life expectancy of > 3 months
Must be able to communicate symptoms indicating potential toxicity of Lidocaine
Must have a competent caregiver in the home overnight after each infusion
Must be willing to remain within 30 minutes of the Cancer Centre during each infusion

Exclusion Criteria:

Clinically significant cardiac disease, i.e, cardiac failure, atrial fibrillation with slow ventricular rate (<60), any degree of heart block
New analgesic treatment initiated in time frame which might have effect within one week of study drug.
Hyper or hypokalemia.
Liver failure (bilirubin ≥ 25 umol/L).
Renal failure (eGFR <50% of normal)
Uncontrolled hypertension (>160/90).
Hypotension (systolic < 90).
Uncontrolled seizures.
Planned initiation of chemotherapy, radiotherapy or bisphosphonates within 30 days prior to treatment with study drug.
Received an investigational drug within 30 days prior to study.
History of allergy to lidocaine or other topical, local or infusional anesthetics.

Sites / Locations

BC Cancer Center of the North
BC Cancer Agency

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine

Placebo (D5W)

Arm Description

Lidocaine

Placebo first as compared with lidocaine first

Outcomes

Primary Outcome Measures

Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores

The primary outcomes measure is a binary variable indicating whether lidocaine caused a reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. Lidocaine will be considered to have caused reduction in cancer pain if the subject had either one of the following episodes and lasting a minimum of 7 days: A 2-point reduction in severity of pain as assessed by the worst pain score in the last 24 hours (question 3) of the Brief Pain Inventory - Short Form (BPI), compared to the BPI pain score at baseline. Or: ≥30% reduction in 24-hour opioid dose.

Secondary Outcome Measures

Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?

Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores

Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?

Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?

Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?

Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?

Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?

Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?

Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?

Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?

Full Information

NCT ID

NCT01384877

First Posted

June 27, 2011

Last Updated

April 29, 2019

Sponsor

British Columbia Cancer Agency

Collaborators

BC Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01384877

Brief Title

Subcutaneous Lidocaine For Cancer-Related Pain

Official Title

A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2017 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

British Columbia Cancer Agency

Collaborators

BC Cancer Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study's primary objective is to test the hypothesis that a single infusion of subcutaneous lidocaine can cause a clinically useful reduction in cancer pain within 48 hours of infusion and lasting a minimum of 7 days. A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour opioid requirement. We will use a composite endpoint of reduction in pain without increase in 24-hr opioid requirement or no decrease in pain with a ≥30% reduction in 24-hour opioid requirement.Subjects will receive either lidocaine or placebo, followed at least 1 week later by the alternate agent.

Detailed Description

Ten mg/kg of lidocaine will be infused subcutaneously via a Baxter infusor over a 5.5 hour period in ambulatory adult cancer patients with a worst pain score of at least 4 out of 10 despite therapy with at least one opioid plus appropriate oral adjuvant analgesic(s). A clinically useful reduction in pain is defined by either a 2-point reduction (on a 0-10 scale) in the worst pain experienced over a 24-hour period, or a ≥30% reduction in 24-hour opioid requirement. The secondary objectives are 1) to determine whether any significant toxicities occur as a result of the infusion. For this study significant toxicity is considered as any adverse event which either leads to the infusion being terminated, or which leads to medical intervention, such as prescribing of another medication or equivalent treatment, 2) to determine the effect of Lidocaine infusion on QOL parameters as measured by the Patient Outcome Scale (POS) Questionnaire and 3) to determine the duration of response to lidocaine infusion. Subjects will fill out Brief Pain Inventory (BPI), Patient Outcome Scale (POS) periodically and medication logs daily while on study. On Days of treatment the subjects will have vital sign monitoring every 15 minutes for the 1st hour and then periodically as set out in the protocol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer-related Pain

Keywords

Pain, Cancer, Lidocaine, Sodium Channel Blockers

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Crossover Assignment

Model Description

One-sided McNemar's tests will be carried out to test whether a single infusion of subcutaneous lidocaine will cause a reduction in cancer pain for both the interim and final analyses at the p-values of 0.00153 and 0.02347 respectively.

Masking

ParticipantCare ProviderInvestigator

Masking Description

Double blind performed by pharmacy. Un blinding to occur at end of study. All subjects to be injected with 1 mL of 1% lidocaine subcutaneous prior to the initiation of the study med infusion, which will act as a masking agent.

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lidocaine

Arm Type

Experimental

Arm Description

Lidocaine

Arm Title

Placebo (D5W)

Arm Type

Placebo Comparator

Arm Description

Placebo first as compared with lidocaine first

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Other Intervention Name(s)

Xylocaine, Lignocaine

Intervention Description

10mg/kg by subcutaneous infusion over 5.5 hours

Intervention Type

Drug

Intervention Name(s)

Placebo (D5W)

Other Intervention Name(s)

5% dextrose in water

Intervention Description

Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)

Primary Outcome Measure Information:

Title

Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores

Description

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?

Description

Time Frame