- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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British Columbia
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Prince George, British Columbia, Canada, V2M 7E9
- BC Cancer Center of the North
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Vancouver, British Columbia, Canada, V5Z 4E6
- BC Cancer Agency
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine
|
10mg/kg by subcutaneous infusion over 5.5 hours
Other Names:
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Placebo Comparator: Placebo (D5W)
Placebo first as compared with lidocaine first
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Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores
Time Frame: 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 and lasting a minimum of 7 days:
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7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
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At most 6 weeks (duration of study)
|
Quality of Life Question: Over the Past 3 Days, Have Other Symptoms e.g. Feeling Sick, Having a Cough or Constipation Been Affecting How You Feel?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
|
At most 6 weeks (duration of study)
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
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At most 6 weeks (duration of study)
|
Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
|
At most 6 weeks (duration of study)
|
Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
|
At most 6 weeks (duration of study)
|
Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
|
At most 6 weeks (duration of study)
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Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
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At most 6 weeks (duration of study)
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Quality of Life Question: Over the Past 3 Days, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
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At most 6 weeks (duration of study)
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Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed?
Time Frame: At most 6 weeks (duration of study)
|
Effect of Lidocaine infusion on Quality Of Life parameters as measured by the Patient Outcome Scale (POS) Questionnaire Baseline scores were compared to an average post treatment score (taken immediately post treatment and on days 2, 3, and 7 following treatment) All POS questions were scored from 0 to 4 with lower scores requiring less clinical attention than higher scores
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At most 6 weeks (duration of study)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippa H Hawley, B.Med, FRCPC, British Columbia Cancer Agency
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Cancer Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- H10-00150
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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