Clinical trial NCT00058357 (phase 3, status: completed)
Conditions: pain, unspecified adult solid tumor, protocol specific
ICD codes: N50.82, R07.2, R07.82, R10.13, R10.33, R14.1, R52, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: lidocaine
SMILES: OC1=CC(Cl)=CC=C1OC1=C(Cl)C=C(Cl)C=C1
Eligibility 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., bupivacaine)

        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