Clinical trial · Interventional
Lidocaine Patch in Treating Cancer Patients With Neuropathic Pain After Surgery
The Efficacy Of Lidocaine Patch In The Management Of Postsurgical Neuropathic Pain In Patients With Cancer: A Phase III Double-Blind, Crossover Study
NCT00058357CI-TRIAL-00022745completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lidocaine | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lidocaine patch
- 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.
- interventionNames
- Drug: lidocaine
- type
- PLACEBO_COMPARATOR
- label
- Placebo patch
- 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.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTCheville AL, Sloan JA, Northfelt DW, Jillella AP, Wong GY, Bearden Iii JD, Liu H, Schaefer PL, Marchello BT, Christensen BJ, Loprinzi CL. Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB). Support Care Cancer. 2009 Apr;17(4):451-60. doi: 10.1007/s00520-008-0542-x. Epub 2009 Jan 13. PMID 19142669