Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Pain

Treatments: Drug: lidocaine; Other: placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00058357

NCCTG-N01CB

CDR0000288824 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Lidocaine patch

Active Comparator group

Description:

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.

Treatment:

Drug: lidocaine

Placebo patch

Placebo Comparator group

Description:

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.

Treatment:

Other: placebo