Subcutaneous Lidocaine For Cancer-Related Pain
|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
|Condition or disease||Intervention/treatment||Phase|
|Cancer-related Pain||Drug: Lidocaine Drug: Placebo (D5W)||Phase 2 Phase 3|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
10mg/kg by subcutaneous infusion over 5.5 hours
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
- 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:
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.
- ≥30% reduction in 24-hour opioid dose.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01384877
|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|
|Principal Investigator:||Philippa H Hawley, B.Med, FRCPC||British Columbia Cancer Agency|