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Subcutaneous Lidocaine For Cancer-Related Pain

Information source: British Columbia Cancer Agency
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer-related Pain

Intervention: Lidocaine (Drug); Placebo (normal saline) (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: British Columbia Cancer Agency

Official(s) and/or principal investigator(s):
Philippa H Hawley, B.Med, FRCPC, Principal Investigator, Affiliation: British Columbia Cancer Agency

Overall contact:
Philippa Hawley, B.Med, FRCPC, Phone: 604-877-6000, Ext: 2707, Email: phawley@bccancer.bc.ca

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. Subjects will receive either lidocaine or placebo, followed at least 3 weeks later by the alternate agent.

Clinical Details

Official title: A Randomized Double Blind Placebo Controlled Crossover Trial of the Use of Subcutaneous Lidocaine Infusion (SCLI) for Chronic Cancer-related Pain

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome: Reduction in worst pain intensity or reduction in 24hr opioid dose of at least 30% without worsening of pain scores

Secondary outcome:

Incidence of adverse events.

Quality of Life

Duration of response to lidocaine infusion.

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 aworst 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

- 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 mmol/L).

- Renal failure (Creatinine clearance <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.

Locations and Contacts

Philippa Hawley, B.Med, FRCPC, Phone: 604-877-6000, Ext: 2707, Email: phawley@bccancer.bc.ca

BC Cancer Agency, Kelowna, British Columbia V1Y 5L3, Canada; Not yet recruiting
Stephen Jefferys, MD, FRCPC, Phone: 250 712-3994, Email: jefferys@shaw.ca
Gillian Fyles, MD, CCFP, Phone: 250 712 3994, Email: gfyles@bccancer.bc.ca
Stephen Jefferys, MD, FRCPC, Principal Investigator

BC Cancer Agency, Vancouver, British Columbia V5Z 4E6, Canada; Recruiting
Philippa H Hawley, B.Med, FRCPC, Phone: 604-877-6000, Ext: 2707, Email: phawley@bccancer.bc.ca
Philippa H Hawley, B.Med, FRCPC, Principal Investigator

Additional Information

Starting date: December 2011
Last updated: July 23, 2015

Page last updated: August 23, 2015

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