Phase 3
N=32
Subcutaneous Lidocaine For Cancer-Related Pain
Cancer-related Pain
Bottom Line
View on ClinicalTrials.gov: NCT01384877 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores — 1; 2; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lidocaine (Drug); Placebo (D5W) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- British Columbia Cancer Agency
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores |
1; 2; 2; 1 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain? |
2.93; 2.67; 2.62; 2.52; 2.52; 2.40 | — |
| SECONDARY 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? |
1.47; 1.5; 1.40; 1.29; 1.43; 0.95 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment? |
2.13; 1.67; 1.92; 1.71; 1.73; 1.47 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You? |
1.60; 1.67; 1.53; 1.71; 1.50; 1.45 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends? |
0.87; 1.33; 1.27; 1.32; 1.12; 1.50 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed? |
1.67; 1.25; 1.55; 1.55; 1.46; 1.23 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person? |
1.73; 1.75; 1.73; 1.52; 1.78; 1.37 | — |
| SECONDARY 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? |
0.67; 0.50; 0.65; 0.77; 0.55; 0.43 | — |
| SECONDARY Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed? |
1.08; 1.0; 1.17; 1.12; 1.20; 0.93 | — |
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.
Eligibility Criteria
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 ( 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.
Data sourced from ClinicalTrials.gov (NCT01384877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.