Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: lidocaine
* Other: placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine patch<br>Participants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area. The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep. | Drug: lidocaine<br> <br> |
| Placebo Comparator: Placebo patch<br>Participants will be instructed to apply a patch or patches (up to 3 maximum simultaneously) directly to the affected area. The patch(es) should be applied during awake hours and then left on continuously for approximately 18 hours or until usual bedtime sleep. | Other: placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity rating (NRS) |  | 4 and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific, pain