Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Lidocaine Patch in Treating Cancer Patients with Neuropathic Pain After Surgery

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N01CB NCT00058357

Objectives

1. Determine whether a lidocaine patch vs placebo improves postsurgical neuropathic pain in cancer patients.
2. Compare the toxic effects of these regimens in these patients.
3. Compare the effect of these regimens on mood states, functional abilities, and overall quality of life of these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

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

Radiotherapy

• No concurrent radiotherapy to the painful area

Surgery

• See Disease Characteristics

Other

• More than 7 days since other prior topical medications to the painful area (including capsaicin)
• 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 applied

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• AST ≤ 2 times upper limit of normal

Renal

• Not specified

Other

• 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)

Expected Enrollment

A total of 100 patients (50 per treatment arm) will be accrued for this study.

Outcomes

Pain intensity rating (NRS)

Pain as assessed by the Brief Pain Inventory-Short Form, Neuropathy Pain Scale, Subject Global Impression of Change, Pain Catastrophizing Scale, Profile of Mood States Short Form, and NCCTG Quality of Life
Incidence of each toxicity reported in each treatment period
Maximum severity reported of each toxicity
Distribution of the overall toxicity score
Proportion of patients who report a preference for lidocaine patch or placebo at study completion
Proportion of patients who terminate treatment prematurely

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.

Cheville AL, Sloan JA, Northfelt DW, et al.: Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer 17 (4): 451-60, 2009.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-284-8964 Email: cloprinzi@mayo.edu
James Bearden, MD, Protocol co-chair		Ph: 864-560-6812; 866-573-3518 Email: jbearden@srhs.com

Registry Information
Official Title		The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study
Trial Start Date		2004-05-14
Trial Completion Date		2009-02-11
Registered in ClinicalTrials.gov		NCT00058357
Date Submitted to PDQ		2003-02-28
Information Last Verified		2006-06-06

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