Pain, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific, pain
Brief summary
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: This randomized phase III trial is studying lidocaine patch to see how well it works compared to a placebo patch in relieving numbness, tingling, and other symptoms of neuropathy in patients who have undergone surgery for cancer.
Detailed description
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.
Interventions
DRUGlidocaine
OTHERplacebo
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity rating (NRS) | 4 and 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 8 weeks |
| Incidence of each toxicity reported in each treatment period | 8 weeks |
| Maximum severity reported of each toxicity | 8 weeks |
| Distribution of the overall toxicity score | 8 weeks |
| Proportion of patients who report a preference for lidocaine patch or placebo at study completion | 8 weeks |
| Proportion of patients who terminate treatment prematurely | up to 8 weeks |
Countries
United States
Outcome results
None listed