RATIONALE: A lidocaine patch may be effective in relieving numbness, tingling, and other symptoms of neuropathy. It is not yet known whether a lidocaine patch is effective in treating neuropathy in patients who have undergone surgery for cancer.

PURPOSE: Randomized phase III trial to study the effectiveness of a lidocaine patch in relieving numbness, tingling, and other symptoms of neuropathy in patients who have undergone surgery for cancer.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific Pain	Drug: lidocaine  Procedure: pain therapy  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES:

• 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 study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

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., bupivicaine)

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• More than 6 weeks since prior 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

Radiotherapy

• No concurrent radiotherapy to the painful area

Surgery

• See Disease Characteristics

Other

• More than 6 weeks since other prior neurotoxic substances
• 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)
• No other concurrent neurotoxic substances
• Concurrent skin lubricants and sunscreen are allowed provided they are not heavily applied

Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Minnesota
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
North Dakota
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States; Recruiting

Study chairs or principal investigators

Gilbert Wong, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000288824; NCCTG-N01CB; NCT00058357
Record last reviewed:  September 2004
Last Updated:  February 4, 2005
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058357
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08