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Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort

26 de junho de 2018 atualizado por: St. Jude Children's Research Hospital

Primary objective:

  1. To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer.

Secondary objectives:

  1. To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.
  2. To investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors.

This study is a randomized double-blind placebo controlled trial of time release melatonin for adult survivors of childhood cancer who demonstrate impaired neurocognitive functioning and/or difficulty falling asleep.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

All participants undergo a general neurocognitive evaluation at baseline and 6-month follow-up, focused on assessment of intelligence, academic skills, attention, processing speed, memory and executive functions.

Sleep parameters using self-report and actigraphy will be assessed at three time points during the study: Baseline, 3-months, and 6-months.

Participants will be divided into 3 mutually exclusive groups:

  • Cohort 1: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes less than once a week during the past month.
  • Cohort 2: Participant has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning at or below the 10th percentile, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes at least once a week during the past month.
  • Cohort 3: Participant is absent of neurocognitive impairment defined as performance >10th percentile on all six measures of attention, memory, and executive functioning, AND has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes > once a week during the past month.

Within each group, participants will be randomly assigned to take either 3 mgs of time release melatonin or placebo 1-2 hours before bedtime each night for 6 months.

Psychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment.

Biological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation.

Tipo de estudo

Intervencional

Inscrição (Real)

911

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38105
        • St. Jude Children's Research Hospital

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • A St. Jude Life participant who was previously treated at St. Jude Children's Research Hospital
  • 10 or more years from diagnosis
  • 18 years of age or older
  • Able to speak and understand the English language
  • Participant has a full scale intelligence quotient (FSIQ) score >79.

  • Cohort 1 participant:

    • Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.
    • Is absent of delayed sleep onset latency defined as an inability to fall asleep within 30 minutes < once a week during the past month.

  • Cohort 2 participant:

    • Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning ≤10th percentile.
    • Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.

  • Cohort 3 participant:

    • Is absent of neurocognitive impairment defined as performance >10th percentile on all six measures of attention, memory, and executive functioning.
    • Has delayed sleep onset latency defined as self-report of an inability to fall asleep within 30 minutes ≥ once a week during the past month.
  • Female participant of childbearing age must not be pregnant or lactating
  • Female research participant of childbearing age and male research participant of child fathering potential agrees to use safe contraceptive methods

Exclusion Criteria:

  • Known allergy to melatonin or any ingredients of the study product or placebo
  • Participant currently is taking melatonin
  • Known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome)
  • Known diabetes mellitus - insulin treated
  • Participant has uncontrolled seizure disorder in past 12 months
  • Reported current illicit drug or alcohol abuse or dependence
  • Reported current major psychiatric illness (i.e. schizophrenia, bipolar disorder)
  • Current treatment with: (1) benzodiazepines or other central nervous system depressants, (2) fluvoxamine, (3) anticoagulants (e.g. coumadin), (4) immunosuppressant or corticosteroids, OR (5) nifedipine (Procardia XL(R))
  • Employed in a position that requires night work (i.e. 10pm to 6am)
  • Females who are pregnant or lactating/nursing
  • History of neurologic event (i.e. traumatic brain injury) unrelated to cancer or its treatment
  • Sensory impairment (vision, hearing) that prohibits completion of neurocognitive examination

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Melatonin
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
Medicamento: melatonin
Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
Outros nomes:
  • N-Acetyl-5-Methoxytryptamine
Comparador de Placebo: Placebo
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
Medicamento: placebo
Placebo tablets to match the melatonin will be comprised of inert substances.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Prazo: Baseline and 6 months after start of therapy
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
Baseline and 6 months after start of therapy

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Sleep Onset Latency as Measured by Actigraphy and Self-report.
Prazo: Baseline and six months after start of therapy
Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only). The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.
Baseline and six months after start of therapy
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.
Prazo: Baseline and six months after start of therapy
Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2). The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. The unit of measurement is a correlation coefficient (Pearson's R2). The range is from -1.0 to 1.0. A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association. A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.
Baseline and six months after start of therapy

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

St. Jude Children's Research Hospital

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Tara Brinkman, Phd, St. Jude Children's Research Hospital

Publicações e links úteis

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Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de fevereiro de 2013

Conclusão Primária (Real)

19 de abril de 2017

Conclusão do estudo (Real)

19 de abril de 2017

Datas de inscrição no estudo

Enviado pela primeira vez

25 de setembro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de outubro de 2012

Primeira postagem (Estimativa)

4 de outubro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de junho de 2018

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de junho de 2018

Última verificação

1 de março de 2018

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • MIND
  • P30CA021765 (Concessão/Contrato do NIH dos EUA)
  • NCI-2012-02053 (Identificador de registro: NCI Clinical Trial Registration Program)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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