NCT01384877

Subcutaneous Lidocaine For Cancer-Related Pain

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer-related Pain

Interventions

Type	Name	Description
DRUG	Lidocaine	10mg/kg by subcutaneous infusion over 5.5 hours
DRUG	Placebo (D5W)	Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)

Timeline

• Start date: 2011-12-01
• Primary completion: 2017-12-01
• Completion: 2019-01-01
• First posted: 2011-06-29
• Last updated: 2019-07-12
• Results posted: 2019-07-12

Locations

2 sites across 1 country: Canada