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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

911 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-06

Study Completion Date

2017-04-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cancer Malignancies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Melatonin

Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.

Group Type ACTIVE_COMPARATOR

melatonin

Intervention Type DRUG

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.

Placebo

Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo tablets to match the melatonin will be comprised of inert substances.

Interventions

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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.

Intervention Type DRUG

placebo

Placebo tablets to match the melatonin will be comprised of inert substances.

Intervention Type DRUG

Other Intervention Names

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N-Acetyl-5-Methoxytryptamine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No