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

26 de junio de 2018 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

911

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

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

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

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

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Melatonin
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
Droga: 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.
Otros nombres:
  • N-Acetyl-5-Methoxytryptamine
Comparador de placebos: Placebo
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
Droga: placebo
Placebo tablets to match the melatonin will be comprised of inert substances.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sleep Onset Latency as Measured by Actigraphy and Self-report.
Periodo de tiempo: 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.
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

St. Jude Children's Research Hospital

Colaboradores

National Cancer Institute (NCI)

Investigadores

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

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.

Enlaces Útiles

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 (Actual)

6 de febrero de 2013

Finalización primaria (Actual)

19 de abril de 2017

Finalización del estudio (Actual)

19 de abril de 2017

Fechas de registro del estudio

Enviado por primera vez

25 de septiembre de 2012

Primero enviado que cumplió con los criterios de control de calidad

2 de octubre de 2012

Publicado por primera vez (Estimar)

4 de octubre de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de junio de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

26 de junio de 2018

Última verificación

1 de marzo de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MIND
  • P30CA021765 (Subvención/contrato del NIH de EE. UU.)
  • NCI-2012-02053 (Identificador de registro: NCI Clinical Trial Registration Program)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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