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Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer Clinical research trials and Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer clinical trial. Participants frequently get the best healthcare available for their Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer  Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
For Condition: neurotoxicity,Quality of Life,unspecified adult solid tumor, protocol specific,Pain
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase III trial to study the effectiveness of lamotrigine in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients who have cancer.
Details: 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), 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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 Performance status - Not specified Life expectancy - At least 6 months Hematopoietic - Not specified 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: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - More than 7 days since prior methotrexate or other dihydrofolate inhibitors Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified 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) - Amifostine - More than 30 days since prior investigational agents for pain control - No other concurrent investigational agents for pain control
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesLoprinzi, , Mayo Clinic Cancer Center
CCOP - Ochsner *Recruiting*
New Orleans, Louisiana, 70121
United States
Recruiting Carl Kardinal 504-842-3910
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54301
United States
Recruiting Anthony Jaslowski 920-884-3135
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting Mark Olsen 918-499-2000
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
Allan Blair Cancer Centre *Recruiting*
Regina, Saskatchewan, S4T 7T1
Canada
Recruiting Muhammad Salim 306-766-2203
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212-4772
United States
Recruiting Jane Raymond 412-359-6147
CCOP - Cedar Rapids Oncology Project *Recruiting*
Cedar Rapids, Iowa, 52403-1206
United States
Recruiting Martin Wiesenfeld 319-363-8303
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Gilbert Wong 507-284-1623
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Atlanta Regional *Recruiting*
Atlanta, Georgia, 30342-1701
United States
Recruiting Thomas Seay 404-851-2340
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Additional Information:
Study ID Numbers: CDR0000322830; NCCTG-N01C3
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068445
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Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
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