Subcutaneous Lidocaine For Cancer-Related Pain

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: British Columbia Cancer Agency
• Collaborator: BC Cancer Foundation
• Treatments: Lidocaine

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 (<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.