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Subcutaneous Lidocaine For Cancer-Related Pain

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ClinicalTrials.gov Identifier: NCT01384877
Recruitment Status : Suspended (study has been suspended pending resolution of staffing issues and external review)
First Posted : June 29, 2011
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Cancer-related Pain Drug: Lidocaine Drug: Placebo (D5W) Phase 2 Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: One-sided McNemar's tests will be carried out to test whether a single infusion of subcutaneous lidocaine will cause a reduction in cancer pain for both the interim and final analyses at the p-values of 0.00153 and 0.02347 respectively.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Double blind performed by pharmacy. Un blinding to occur at end of study. All subjects to be injected with 1 mL of 1% lidocaine subcutaneous prior to the initiation of the study med infusion, which will act as a masking agent.
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
Study Start Date : December 2011
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Lidocaine
Lidocaine
Drug: Lidocaine
10mg/kg by subcutaneous infusion over 5.5 hours
Other Names:
  • Xylocaine
  • Lignocaine
Placebo Comparator: Placebo (D5W)
Placebo first as compared with lidocaine first
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)
Other Name: 5% dextrose in water


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

    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 :
  1. Incidence of adverse events. [ Time Frame: At least 6 weeks: for 3 weeks following each treatment (lidocaine or placebo) at most 3 weeks apart ]
    Incidence of adverse events.

  2. Quality of Life [ Time Frame: At most 6 weeks (duration of study) ]
    Effect of Lidocaine infusion on QOL parameters as measured by the Patient Outcome Scale (POS) Questionnaire

  3. Duration of response to lidocaine infusion. [ Time Frame: At most 6 weeks (duration of study) ]
    Duration of response to lidocaine infusion.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384877


Locations
Canada, British Columbia
BC Cancer Center of the North
Prince George, British Columbia, Canada, V2M 7E9
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
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

Responsible Party: Pippa Hawley, Palliative Medicine Specialist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01384877     History of Changes
Other Study ID Numbers: H10-00150
First Posted: June 29, 2011    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Cancer Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action