Subcutaneous Lidocaine For Cancer-Related Pain
CompletedPhase 2, Phase 3NCT01384877
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Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain
- Conditions
- Cancer-related Pain
- Interventions
- Drug: Lidocaine
- Drug: Placebo (D5W)
- Sponsor
- British Columbia Cancer Agency
- Collaborators
- BC Cancer Foundation
- Start date
- 2011-12
- Primary completion
- 2017-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- Canada
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Canadian sites (2)
| Facility | City | Province |
|---|---|---|
| BC Cancer Center of the North | Prince George | British Columbia |
| BC Cancer Agency | Vancouver | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01384877