Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
An Exploratory Trial of Donepezil and Vitamin E to Prevent Cognitive Dysfunction in Patients With Small Cell Lung Cancer (SCLC) After Cancer Treatment Which Includes Prophylatic Cranial Irradiation (PCI)
RATIONALE: Donepezil and vitamin E may be able to decrease side effects caused by radiation therapy given to prevent brain metastases in patients with small cell lung cancer. It is not yet known if donepezil and vitamin E are effective in preventing side effects caused by radiation therapy to the head.
PURPOSE: Randomized phase III trial to determine the effectiveness of donepezil and vitamin E in preventing side effects caused by radiation therapy given to prevent brain metastases in patients who have small cell lung cancer.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with donepezil and vitamin E vs placebo.
- Determine the toxicity of donepezil and vitamin E in these patients.
- Determine whether preserved cognitive function favorably impacts quality of life in these patients.
- Determine the natural history of cognitive decline in these patients after cancer treatment.
- Determine whether genotypes of apolipoprotein E predict decline in cognitive function among patients at risk for treatment-associated dementia and whether these genotypes predict duration of disease-free survival among patients who have achieved complete response after treatment for SCLC.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to cognitive function (normal vs mild to moderate dysfunction vs severe dysfunction) and age (60 and under vs over 60).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral donepezil daily and vitamin E twice daily.
- Arm II: Patients receive oral placebos according to the same schedule as the study drugs in arm I.
All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale.
Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study.
Quality of life and depression are assessed at baseline and then every 3 months during study.
Patients are followed every 6 months.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Estados Unidos, 61602
- 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, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Estados Unidos, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Estados Unidos, 67214-3882
- CCOP - Wichita
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic Cancer Center
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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
- Medcenter One Health System
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Fargo, North Dakota, Estados Unidos, 58122
- CCOP - Merit Care Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15212-4772
- Allegheny General Hospital
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
DISEASE CHARACTERISTICS:
Diagnosis of small cell lung cancer (SCLC)
Must meet one of the following conditions:
- Enrolled no more than 4 weeks before initiation of prophylactic cranial irradiation (PCI) OR
- Enrolled no more than 10 days after initiation of PCI
- Limited or extensive stage SCLC with complete response (CR) outside chest allowed
- Must have CR or minimal disease after completion of intended course of chemotherapy
- No disease progression since initiation of PCI
- No prior or concurrent CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 2 times upper limit of normal
Cardiovascular:
- No sick sinus syndrome or other symptomatic supraventricular conduction disorders even if symptoms currently controlled by antiarrhythmics
Pulmonary:
- No history of asthma or chronic obstructive pulmonary disease requiring chronic oxygen therapy
Other:
- No medical or psychiatric condition that would increase risk
- No seizure disorder
- No ongoing alcohol abuse
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- See Disease Characteristics
- No concurrent anticancer chemotherapy
Other:
- No concurrent medications that would impair baseline cognitive function or are likely to be dose escalated over the next few months
- No other concurrent vitamin E
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: donepezil + vitamin E
Patients receive oral donepezil daily and vitamin E twice daily. All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale. Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study. Quality of life and depression are assessed at baseline and then every 3 months during study. Patients are followed every 6 months. |
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Comparador de Placebo: placebo
Patients receive oral placebo twice daily. All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale. Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study. Quality of life and depression are assessed at baseline and then every 3 months during study. Patients are followed every 6 months. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with donepezil and vitamin E vs placebo
Prazo: Up to 6 months
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Up to 6 months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Qualidade de vida
Prazo: Até 6 meses
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Até 6 meses
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Sintomas Comportamentais
- Transtornos Mentais, Desordem Mental
- Doenças do Sistema Nervoso
- Doenças Respiratórias
- Neoplasias
- Doenças pulmonares
- Neoplasias por local
- Manifestações Neurológicas
- Confusão
- Manifestações Neurocomportamentais
- Distúrbios Neurocognitivos
- Neoplasias do Trato Respiratório
- Neoplasias Torácicas
- Carcinoma Broncogênico
- Neoplasias Brônquicas
- Depressão
- Delírio
- Neoplasias Pulmonares
- Carcinoma pulmonar de pequenas células
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes colinérgicos
- Inibidores Enzimáticos
- Agentes de proteção
- Micronutrientes
- Vitaminas
- Antioxidantes
- Agentes Nootrópicos
- Inibidores da colinesterase
- Vitamina E
- Donepezil
Outros números de identificação do estudo
- NCCTG-N99C5
- CDR0000068206 (Identificador de registro: PDQ (Physician Data Query))
- NCI-P00-0169
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