Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Lidocaine

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