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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 : July 11, 2018
Sponsor:
Collaborator:
BC Cancer Foundation
Information provided by (Responsible Party):
Pippa Hawley, British Columbia Cancer Agency

June 27, 2011
June 29, 2011
July 11, 2018
December 2011
August 2018   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01384877 on ClinicalTrials.gov Archive Site
  • 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.
  • 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
  • Duration of response to lidocaine infusion. [ Time Frame: At most 6 weeks (duration of study) ]
    Duration of response to lidocaine infusion.
  • Incidence of adverse events. [ Time Frame: At least 6 weeks: for 3 weeks following each treatment (lidocaine or placebo) at least 3 weeks apart ]
    Incidence of adverse events.
  • Quality of Life [ Time Frame: At least 6 weeks (duration of study) ]
    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) ]
    Duration of response to lidocaine infusion.
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 2
Phase 3
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
Cancer-related Pain
  • Drug: Lidocaine
    10mg/kg by subcutaneous infusion over 5.5 hours
    Other Names:
    • Xylocaine
    • Lignocaine
  • 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
  • Experimental: Lidocaine
    Lidocaine
    Intervention: Drug: Lidocaine
  • Placebo Comparator: Placebo (D5W)
    Placebo first as compared with lidocaine first
    Intervention: Drug: Placebo (D5W)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
Same as current
August 2019
August 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01384877
H10-00150
Yes
Not Provided
Not Provided
Pippa Hawley, British Columbia Cancer Agency
British Columbia Cancer Agency
BC Cancer Foundation
Principal Investigator: Philippa H Hawley, B.Med, FRCPC British Columbia Cancer Agency
British Columbia Cancer Agency
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP