Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 10, 2003
Last updated: August 19, 2009
Last verified: September 2004

RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in treating peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients with cancer.

Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: lamotrigine
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2004
Detailed Description:


  • Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer.
  • Compare symptom distress, mood states, functional abilities, and overall quality of life of patients treated with these agents.
  • Determine the toxic effects of lamotrigine in these patients.

OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to neurotoxic chemotherapy received (taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other), status of neurotoxic chemotherapy (actively receiving therapy vs discontinued or completed), and duration of pain or neuropathy symptoms (1-3 months vs 3-6 months vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks.
  • Arm II: Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks.

In both arms, treatment continues for 10 weeks in the absence of unacceptable toxicity.

Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks.

Patients are followed at 3-7 days.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


  • Diagnosis of cancer
  • Received, or are currently receiving, neurotoxic chemotherapy, including any of the following:

    • Taxanes (e.g., paclitaxel or docetaxel)
    • Platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin)
    • Vinca alkaloids (e.g., vincristine or vinblastine)
  • Experiencing pain or symptoms of peripheral neuropathy for at least 1 month attributed to chemotherapy

    • Average daily pain rating of at least 4 out of 10 OR
    • Peripheral neuropathy at least grade 1 out of 3 using ECOG sensory neuropathy rating



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • At least 6 months


  • Not specified


  • Bilirubin < 2 times upper limit of normal (ULN)


  • Creatinine ≤ 1.5 times ULN


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reaction or intolerance to lamotrigine
  • No extreme difficulty swallowing pills
  • No other identified causes of painful paresthesia preceding chemotherapy, including any of the following:

    • Radiation or malignant plexopathy
    • Lumbar or cervical radiculopathy
    • Pre-existing peripheral neuropathy of another etiology, such as any of the following:

      • Cyanocobalamin deficiency
      • AIDS
      • Monoclonal gammopathy
      • Diabetes
      • Heavy metal poisoning amyloidosis
      • Syphilis
      • Hyperthyroidism or hypothyroidism
      • Inherited neuropathy
  • No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study participation
  • Able to complete questionnaires


Biologic therapy

  • Not specified


  • See Disease Characteristics
  • More than 7 days since prior methotrexate or other dihydrofolate inhibitors

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • More than 7 days since prior, and no concurrent use of any of the following:

    • Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, or desipramine)

      • Concurrent selective serotonin reuptake inhibitors allowed
    • Monoamine oxidase inhibitors
    • Opioid analgesics
    • Anticonvulsants (e.g., gabapentin, topiramate, valproic acid, or clonazepam)
    • Adjuvant analgesics (e.g., mexiletine)

      • Prior nonsteroidal anti-inflammatory drugs allowed
    • Topical analgesics (e.g., lidocaine gel or patch) to the affected area
    • Amifostine
  • More than 30 days since prior investigational agents for pain control
  • No other concurrent investigational agents for pain control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00068445

  Show 23 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Study Chair: Ravi D. Rao, MD, MBBS Mayo Clinic
Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
Renno SI, Rao RD, Sloan J, et al.: The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3. [Abstract] J Clin Oncol 24 (Suppl 18): A-8530, 475s, 2006. Identifier: NCT00068445     History of Changes
Other Study ID Numbers: CDR0000322830, NCCTG-N01C3
Study First Received: September 10, 2003
Last Updated: August 19, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Chemically-Induced Disorders
Nervous System Diseases
Neuromuscular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers processed this record on June 30, 2015