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

Information source: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: lamotrigine (Drug); Placebo (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Alliance for Clinical Trials in Oncology

Official(s) and/or principal investigator(s):
Ravi D. Rao, MD, MBBS, Study Chair, Affiliation: Mayo Clinic


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.

Clinical Details

Official title: The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Primary outcome: Reduction of pain and symptoms of chemotherapy-induced peripheral neuropathy

Secondary outcome: Overall quality of life

Detailed description: 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.



- Diagnosis of cancer

- Received, or are currently receiving, neurotoxic chemotherapy, including any of the


- 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


- 18 and over

Life expectancy

- At least 6 months


- 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


- Cyanocobalamin deficiency


- 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


- See Disease Characteristics

- More than 7 days since prior methotrexate or other dihydrofolate inhibitors


- 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

Locations and Contacts

Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States

Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States

CCOP - Atlanta Regional, Atlanta, Georgia 30342-1701, United States

MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States

CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615-7828, United States

CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States

CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States

CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1854, United States

Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center, Sioux City, Iowa 51101-1733, United States

CCOP - Wichita, Wichita, Kansas 67214-3882, United States

CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States

CCOP - Duluth, Duluth, Minnesota 55805, United States

Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States

Coborn Cancer Center, Saint Cloud, Minnesota 56303, United States

CCOP - Metro-Minnesota, Saint Louis Park, Minnesota 55416, United States

CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States

Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota 58501-5505, United States

CCOP - Dayton, Dayton, Ohio 45429, United States

CCOP - Toledo Community Hospital, Toledo, Ohio 43623-3456, United States

CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States

Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States

CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States

CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay, Wisconsin 54301, United States

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: February 2004
Last updated: July 7, 2015

Page last updated: August 23, 2015

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