Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
3 de abril de 2018 actualizado por: Alliance for Clinical Trials in Oncology
The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
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.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
131
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic Scottsdale
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic - Jacksonville
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342-1701
- CCOP - Atlanta Regional
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96813
- MBCCOP - Hawaii
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Illinois
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Peoria, Illinois, Estados Unidos, 61615-7828
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Estados Unidos, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Estados Unidos, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Estados Unidos, 50309-1854
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- CCOP - Michigan Cancer Research Consortium
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Minnesota
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Duluth, Minnesota, Estados Unidos, 55805
- CCOP - Duluth
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Estados Unidos, 56303
- Coborn Cancer Center
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Estados Unidos, 58501-5505
- Cancer Care Center at Medcenter One Hospital
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Ohio
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Dayton, Ohio, Estados Unidos, 45429
- CCOP - Dayton
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Toledo, Ohio, Estados Unidos, 43623-3456
- CCOP - Toledo Community Hospital
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- CCOP - Upstate Carolina
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South Dakota
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Rapid City, South Dakota, Estados Unidos, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Estados Unidos, 57104
- CCOP - Sioux Community Cancer Consortium
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Wisconsin
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Green Bay, Wisconsin, Estados Unidos, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
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Otro: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
Periodo de tiempo: From baseline to week 10
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The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below.
The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.
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From baseline to week 10
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Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
Periodo de tiempo: From baseline to week 10
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The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below.
The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.
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From baseline to week 10
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
Periodo de tiempo: From baseline to week 10
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The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below.
The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. Time Frame: Up to 1 week post-treatment |
From baseline to week 10
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Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
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From baseline to week 10
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Change in POMS Total Score [Week 10 Minus Baseline]
Periodo de tiempo: From baseline to week 10
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The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below.
The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week.
The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.
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From baseline to week 10
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2004
Finalización primaria (Actual)
1 de mayo de 2006
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
10 de septiembre de 2003
Primero enviado que cumplió con los criterios de control de calidad
10 de septiembre de 2003
Publicado por primera vez (Estimar)
11 de septiembre de 2003
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de mayo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
3 de abril de 2018
Última verificación
1 de abril de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Trastornos inducidos químicamente
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Envenenamiento
- Enfermedades del Sistema Nervioso Periférico
- Síndromes de neurotoxicidad
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Depresores del sistema nervioso central
- Agentes antipsicóticos
- Agentes tranquilizantes
- Drogas psicotropicas
- Moduladores de transporte de membrana
- Anticonvulsivos
- Bloqueadores de canales de sodio
- Hormonas y agentes reguladores del calcio
- Bloqueadores de los canales de calcio
- Lamotrigina
Otros números de identificación del estudio
- NCCTG-N01C3
- CDR0000322830 (Identificador de registro: PDQ (Physician Data Query))
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .