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| Name | Class |
|---|---|
| BC Cancer Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Lidocaine |
|
| Placebo (D5W) | Placebo Comparator | Placebo first as compared with lidocaine first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | 10mg/kg by subcutaneous infusion over 5.5 hours |
|
| 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 | 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:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain? | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa H Hawley, B.Med, FRCPC | British Columbia Cancer Agency | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Center of the North | Prince George | British Columbia | V2M 7E9 | Canada | ||
| BC Cancer Agency |
One (1) participant signed the informed consent form but withdrew from the study before receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lidocaine/Placebo | Patient received Lidocaine in the first period followed by placebo in the second period. Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs |
| FG001 | Placebo (D5W)/Lidocaine | Patient received Placebo in the first period followed by Lidocaine in the second period. Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment 1 |
| |||||||||||||
| Treatment 2 |
|
The overall number in the baseline analysis include all participants who signed the informed consent form. One (1) participant included in this analysis withdrew before receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lidocaine/Placebo | Patient received Lidocaine in the first period followed by placebo in the second period. Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Reduction in Worst Pain Intensity or Reduction in 24hr Opioid Dose of at Least 30% Without Worsening of Pain Scores | 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:
| Participants were included in analysis if they completed both treatment periods and all the data was collected for both treatment periods | Posted | Count of Participants | Participants | 7 days |
|
21 days after each treatment, up to 6 weeks total
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lidocaine | Lidocaine Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Philippa Hawley | BC Cancer | 604-877-6000 | 67-2752 | phawley@bccancer.bc.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2017 | May 7, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D005947 | Glucose |
| D014867 | Water |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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.
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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.
| Placebo (D5W) | Drug | Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs) |
|
|
| 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? | 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? | 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 Any of Your Family or Friends Been Anxious or Worried About You? | 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? | 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? | 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 Felt Good About Yourself as a Person? | 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, How Much Time do You Feel Has Been Wasted on Appointments Relating to Your Healthcare e.g. Waiting Around for Transport or Repeating Tests? | 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 Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed? | 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) |
| Vancouver |
| British Columbia |
| V5Z 4E6 |
| Canada |
| NOT COMPLETED |
|
|
| Placebo (D5W)/Lidocaine |
Patient received Placebo in the first period followed by Lidocaine in the second period. Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Palliative Performance Scale | Palliative Performance Scale (PPS) PPS ranges from 100% to 0% 100%: Patient has full ambulation; normal activity and work; no evidence of disease; full self-care; normal intake; full conscious level 50%: Patient mainly sit/lie; unable to do any work; extensive disease; considerable assistance required for self-care; normal or reduced intake; full or confusion level of consciousness 0% death | Count of Participants | Participants |
|
Patient received Lidocaine in the first period followed by placebo in the second period. Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs |
| OG001 | Placebo (D5W)/Lidocaine | Patient received Placebo in the first period followed by Lidocaine in the second period. Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over 5.5 hrs Lidocaine: 10mg/kg by subcutaneous infusion over 5.5 hours |
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | 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? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Anxious or Worried About Your Illness or Treatment? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have Any of Your Family or Friends Been Anxious or Worried About You? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have You Been Able to Share How You Are Feeling With Your Family or Friends? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have You Been Feeling Depressed? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have You Felt Good About Yourself as a Person? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | 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? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| Secondary | Quality of Life Question: Over the Past 3 Days, Have Any Practical Matters Resulting From Your Illness, Either Financial or Personal, Been Addressed? | 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 | Participants included in this analysis completed both treatment periods and returned all their questionnaires at the end of the study | Posted | Mean | Standard Deviation | score on a scale | At most 6 weeks (duration of study) |
|
|
|
| 1 |
| 32 |
| 0 |
| 32 |
| 3 |
| 32 |
| EG001 | Placebo (D5W) | Placebo first as compared with lidocaine first Placebo (D5W): Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs) | 2 | 32 | 0 | 32 | 2 | 32 |
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Feet Swollen | General disorders | Non-systematic Assessment |
|
| Throbbing sensation from waist down | Nervous system disorders | Non-systematic Assessment |
|
| Neck Hurts | General disorders | Non-systematic Assessment |
|
| Blood in Urine | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment | above right hip going up back and down leg |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Swelling at needle site | General disorders | Non-systematic Assessment |
|
| Redness at needle site | General disorders | Non-systematic Assessment |
|
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| Aniline Compounds |
| D000588 | Amines |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| 80-89% |
|
| 70-79% |
|
| 60-69% |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|
| Period 2 |
|