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The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study

Phase 3
18 Years
Not Enrolling
Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study


- Determine whether a lidocaine patch vs placebo improves postsurgical neuropathic pain
in cancer patients.

- Compare the toxic effects of these regimens in these patients.

- Compare the effect of these regimens on mood states, functional abilities, and overall
quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to etiology of pain (breast surgery vs lung surgery vs amputation vs
other), duration of pain (1-3 months vs 4-6 months vs more than 6 months), and current
analgesic regimen (opioids [including tramadol] vs antidepressants vs anticonvulsants vs
combination vs other vs none). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive a lidocaine transdermal patch (up to 3 patches) applied
directly to the painful area for 18 hours once daily. Treatment continues for 4 weeks
in the absence of unacceptable toxicity. At the end of week 4, patients cross over to
arm II.

- Arm II: Patients receive a placebo transdermal patch applied to the painful area as in
arm I. At the end of week 4, patients cross over to arm I.

Pain and quality of life are assessed at baseline and weeks 4 and 8.

Patients are followed at 3-7 days.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this

Inclusion Criteria


- Underwent surgical procedure for cancer diagnosis or treatment

- Experiencing persistent pain for at least 1 month

- Pain must have neuropathic features (e.g., burning, shooting, stabbing,
tingling, or pain from light touch)

- Anatomically related to the surgical site and compatible with nerve injury

- Pain rating of at least 4 out of 10 on the pain scale

- No pain of multiple etiologies at the proposed treatment site (e.g., pain of
neuropathic and muscular or skeletal origin)

- Painful area must be no larger than can be covered by 3 lidocaine patches* NOTE:
*Each patch size is 5.5 x 4 inches

- No skin disease, breakdown, infection, or extreme thinning at the site of pain

- No skin or soft tissue malignancy in the painful area



- 18 and over

Performance status

- Not specified

Life expectancy

- At least 6 months


- Not specified


- AST ≤ 2 times upper limit of normal


- Not specified


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Able to understand and complete questionnaires

- No recent history of or concurrent drug or alcohol abuse

- No mental or psychiatric condition that would preclude giving informed consent

- No history of allergic reaction or intolerance to lidocaine or other amide local
anesthetics (e.g., bupivacaine)


Biologic therapy

- Not specified


- No prior neurotoxic chemotherapy* with pain in the same area as postsurgical
neuropathic pain, except for pain that was present before neurotoxic chemotherapy

- No concurrent neurotoxic chemotherapy* NOTE: *Including taxanes (e.g., paclitaxel or
docetaxel), platinum-based compounds (e.g., cisplatin or carboplatin), or vinca
alkaloids (e.g., vincristine or vinblastine)

Endocrine therapy

- More than 7 days since prior topical corticosteroids to the painful area

- No new corticosteroids may be initiated during study participation


- No concurrent radiotherapy to the painful area


- See Disease Characteristics


- More than 7 days since other prior topical medications to the painful area (including

- No change in current analgesic regimen within the past 10 days

- No new analgesic or adjuvant drugs (e.g., antidepressants, anticonvulsants, or
anxiolytics) may be initiated during study participation

- Concurrent stable doses of nonopioid, opioid, and adjuvant analgesic drugs are
allowed (including antidepressants or anticonvulsants)

- No concurrent class I antiarrhythmic drugs (e.g., tocainide and mexiletine)

- Concurrent skin lubricants and sunscreen are allowed provided they are not heavily

Type of Study:


Study Design:

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

Outcome Measure:

Pain intensity rating (NRS)

Outcome Time Frame:

4 and 8 weeks

Safety Issue:


Principal Investigator

Charles L. Loprinzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 2004

Completion Date:

July 2007

Related Keywords:

  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • pain
  • Neuralgia



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