Subcutaneous Lidocaine For Cancer-Related Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by British Columbia Cancer Agency.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
Pippa Hawley, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01384877
First received: June 27, 2011
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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. Subjects will receive either lidocaine or placebo, followed at least 3 weeks later by the alternate agent.


Condition Intervention Phase
Cancer-related Pain
Drug: Lidocaine
Drug: Placebo (normal saline)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain

Resource links provided by NLM:


Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:
  • Reduction in worst pain intensity or reduction in 24hr opioid dose of at least 30% without worsening of pain scores [ Time Frame: within 48 hours of infusion and lasting a minimum of 7 days ] [ Designated as safety issue: No ]

    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 lasting a minimum of 7 days:

    1. 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:

    2. ≥30% reduction in 24-hour opioid dose.


Secondary Outcome Measures:
  • Incidence of adverse events. [ Time Frame: At least 6 weeks: for 3 weeks following each treatment (lidocaine or placebo) at least 3 weeks apart ] [ Designated as safety issue: Yes ]
    Incidence of adverse events.

  • Quality of Life [ Time Frame: At least 6 weeks (duration of study) ] [ Designated as safety issue: No ]
    Effect of Lidocaine infusion on QOL parameters as measured by the Patient Outcome Scale (POS) Questionnaire

  • Duration of response to lidocaine infusion. [ Time Frame: At least 6 weeks (duration of study) ] [ Designated as safety issue: No ]
    Duration of response to lidocaine infusion.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
Lidocaine
Drug: Lidocaine
10mg/kg by subcutaneous infusion over 5.5 hours
Other Names:
  • Xylocaine
  • Lignocaine
Placebo (normal saline)
Placebo first as compared with lidocaine first
Drug: Placebo (normal saline)
Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)

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 aworst 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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 mmol/L).
  • Renal failure (Creatinine clearance <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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384877

Contacts
Contact: Philippa Hawley, B.Med, FRCPC 604-877-6000 ext 2707 phawley@bccancer.bc.ca
Contact: Stephen Jefferys, MD, FRCPC 250 712-3994 efferys@shaw.ca

Locations
Canada, British Columbia
BC Cancer Agency Not yet recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Stephen Jefferys, MD, FRCPC    250 712-3994    jefferys@shaw.ca   
Contact: Gillian Fyles, MD, CCFP    250 712 3994    gfyles@bccancer.bc.ca   
Principal Investigator: Stephen Jefferys, MD, FRCPC         
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Philippa H Hawley, B.Med, FRCPC    604-877-6000 ext 2707    phawley@bccancer.bc.ca   
Principal Investigator: Philippa H Hawley, B.Med, FRCPC         
Sponsors and Collaborators
British Columbia Cancer Agency
BC Cancer Foundation
Investigators
Principal Investigator: Philippa H Hawley, B.Med, FRCPC British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: Pippa Hawley, Palliative Medicine Specialist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01384877     History of Changes
Other Study ID Numbers: H10-00150
Study First Received: June 27, 2011
Last Updated: March 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by British Columbia Cancer Agency:
Pain
Cancer
Lidocaine
Sodium Channel Blockers

Additional relevant MeSH terms:
Lidocaine
Sodium Channel Blockers
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014