Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
26 juni 2018 bijgewerkt door: St. Jude Children's Research Hospital
Primary objective:
- To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer.
Secondary objectives:
- To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.
- 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
911
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Tennessee
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Memphis, Tennessee, Verenigde Staten, 38105
- St. Jude Children's Research Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Actieve vergelijker: Melatonin
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
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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.
Andere namen:
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Placebo-vergelijker: Placebo
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
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Placebo tablets to match the melatonin will be comprised of inert substances.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
Tijdsspanne: Baseline and 6 months after start of therapy
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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.
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Baseline and 6 months after start of therapy
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Sleep Onset Latency as Measured by Actigraphy and Self-report.
Tijdsspanne: Baseline and six months after start of therapy
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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.
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Baseline and six months after start of therapy
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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.
Tijdsspanne: Baseline and six months after start of therapy
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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.
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Baseline and six months after start of therapy
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Tara Brinkman, PhD, St. Jude Children's Research Hospital
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 februari 2013
Primaire voltooiing (Werkelijk)
19 april 2017
Studie voltooiing (Werkelijk)
19 april 2017
Studieregistratiedata
Eerst ingediend
25 september 2012
Eerst ingediend dat voldeed aan de QC-criteria
2 oktober 2012
Eerst geplaatst (Schatting)
4 oktober 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
28 juni 2018
Laatste update ingediend die voldeed aan QC-criteria
26 juni 2018
Laatst geverifieerd
1 maart 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- MIND
- P30CA021765 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2012-02053 (Register-ID: NCI Clinical Trial Registration Program)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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