Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
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ClinicalTrials.gov Identifier: NCT00068445 |
Recruitment Status
:
Completed
First Posted
: September 11, 2003
Last Update Posted
: July 14, 2016
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific | Drug: lamotrigine Other: Placebo | Phase 3 |
OBJECTIVES:
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 131 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
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 |
Study Start Date : | February 2004 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm I - lamotrigine
Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks. 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. |
Drug: lamotrigine |
Arm II - placebo
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. 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. |
Other: Placebo |
- Reduction of pain and symptoms of chemotherapy-induced peripheral neuropathy [ Time Frame: Up to 1 week post-treatment ]
- Overall quality of life [ Time Frame: Up to 1 week post-treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Life expectancy
- At least 6 months
Hepatic
- Bilirubin < 2 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.5 times ULN
Other
- 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
PRIOR CONCURRENT THERAPY:
Chemotherapy
- See Disease Characteristics
- More than 7 days since prior methotrexate or other dihydrofolate inhibitors
Other
-
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00068445

United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Georgia | |
CCOP - Atlanta Regional | |
Atlanta, Georgia, United States, 30342-1701 | |
United States, Hawaii | |
MBCCOP - Hawaii | |
Honolulu, Hawaii, United States, 96813 | |
United States, Illinois | |
CCOP - Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61615-7828 | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
United States, Iowa | |
CCOP - Cedar Rapids Oncology Project | |
Cedar Rapids, Iowa, United States, 52403-1206 | |
CCOP - Iowa Oncology Research Association | |
Des Moines, Iowa, United States, 50309-1854 | |
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center | |
Sioux City, Iowa, United States, 51101-1733 | |
United States, Kansas | |
CCOP - Wichita | |
Wichita, Kansas, United States, 67214-3882 | |
United States, Michigan | |
CCOP - Michigan Cancer Research Consortium | |
Ann Arbor, Michigan, United States, 48106 | |
United States, Minnesota | |
CCOP - Duluth | |
Duluth, Minnesota, United States, 55805 | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
Coborn Cancer Center | |
Saint Cloud, Minnesota, United States, 56303 | |
CCOP - Metro-Minnesota | |
Saint Louis Park, Minnesota, United States, 55416 | |
United States, Nebraska | |
CCOP - Missouri Valley Cancer Consortium | |
Omaha, Nebraska, United States, 68106 | |
United States, North Dakota | |
Cancer Care Center at Medcenter One Hospital | |
Bismarck, North Dakota, United States, 58501-5505 | |
United States, Ohio | |
CCOP - Dayton | |
Dayton, Ohio, United States, 45429 | |
CCOP - Toledo Community Hospital | |
Toledo, Ohio, United States, 43623-3456 | |
United States, South Carolina | |
CCOP - Upstate Carolina | |
Spartanburg, South Carolina, United States, 29303 | |
United States, South Dakota | |
Rapid City Regional Hospital | |
Rapid City, South Dakota, United States, 57709 | |
CCOP - Sioux Community Cancer Consortium | |
Sioux Falls, South Dakota, United States, 57104 | |
United States, Wisconsin | |
CCOP - St. Vincent Hospital Cancer Center, Green Bay | |
Green Bay, Wisconsin, United States, 54301 |
Study Chair: | Ravi D. Rao, MD, MBBS | Mayo Clinic |
Publications of Results:
Responsible Party: | Alliance for Clinical Trials in Oncology |
ClinicalTrials.gov Identifier: | NCT00068445 History of Changes |
Other Study ID Numbers: |
NCCTG-N01C3 CDR0000322830 ( Registry Identifier: PDQ (Physician Data Query) ) |
First Posted: | September 11, 2003 Key Record Dates |
Last Update Posted: | July 14, 2016 |
Last Verified: | July 2016 |
Keywords provided by Alliance for Clinical Trials in Oncology:
neurotoxicity pain unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
Peripheral Nervous System Diseases Neurotoxicity Syndromes Neuromuscular Diseases Nervous System Diseases Poisoning Chemically-Induced Disorders Lamotrigine Anticonvulsants Calcium Channel Blockers |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Physiological Effects of Drugs Voltage-Gated Sodium Channel Blockers Sodium Channel Blockers |