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


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer-related Pain

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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. Or: ≥30% reduction in 24-hour opioid dose.

Outcome Time Frame:

within 48 hours of infusion and lasting a minimum of 7 days

Safety Issue:

No

Principal Investigator

Philippa H Hawley, B.Med, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

British Columbia Cancer Agency

Authority:

Canada: Health Canada

Study ID:

H10-00150

NCT ID:

NCT01384877

Start Date:

December 2011

Completion Date:

Related Keywords:

  • Cancer-related Pain
  • Pain
  • Cancer
  • Lidocaine
  • Sodium Channel Blockers

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