Subcutaneous Lidocaine For Cancer-Related Pain

NCT01384877 | Completed Phase 2 Results DMC

• 1 other identifier: H10-00150
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Cancer-related Pain

Keywords

Pain; Cancer; Lidocaine; Sodium Channel Blockers

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  7 days

Secondary Outcomes (9)

• Quality of Life Question: Over the Past 3 Days, Have You Been Affected by Pain?

  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?

  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?

  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?

  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?

  At most 6 weeks (duration of study)

Study Arms (2)

Lidocaine

EXPERIMENTAL

Lidocaine

Drug: Lidocaine

Placebo (D5W)

PLACEBO COMPARATOR

Placebo first as compared with lidocaine first

Drug: Placebo (D5W)

Interventions

Lidocaine DRUG

10mg/kg by subcutaneous infusion over 5.5 hours

Also known as: Xylocaine, Lignocaine

Lidocaine

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)

Also known as: 5% dextrose in water

Placebo (D5W)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• BC Cancer Foundation: collaborator

Study Sites (2)

BC Cancer Center of the North

Prince George, British Columbia, V2M 7E9, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Cancer Pain; Pain; Neoplasms

Interventions

Lidocaine; Glucose; Water

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hexoses; Monosaccharides; Sugars; Carbohydrates; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Results Point of Contact

• Title: Dr. Philippa Hawley
• Organization: BC Cancer

phawley@bccancer.bc.ca

604-877-6000

Study Officials

• Philippa H Hawley, B.Med, FRCPC

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Palliative Medicine Specialist

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: June 29, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2019
• Last Updated: July 12, 2019
• Results First Posted: July 12, 2019

Record last verified: 2019-04

Locations

CA (2)