Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/30/2018 |
| Start Date: | February 6, 2013 |
| End Date: | April 19, 2017 |
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.
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.
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.
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.
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
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Tara Brinkman, PhD
Phone: 866-278-5833
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