Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
18 Years
N/A
Both
Cancer Malignancies
Trial Information
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
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.
Inclusion Criteria:
- Previously treated at St. Jude Children's Research Hospital
- 10 or more years from diagnosis
- Verbal IQ score > 79
- Performance IQ score > 79
- 18 years of age or older
- Able to speak and understand the English language
- 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
- Known 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 substance 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Neurocognitive function as measured by performance on standardized tests of attention, memory, and executive function.
Outcome Description:
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2). The measures will be analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups.
Outcome Time Frame:
Baseline and 6 months after start of therapy
Safety Issue:
No
Principal Investigator
Tara Brinkman, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
St. Jude Children's Research Hospital
Authority:
United States: Institutional Review Board
Study ID:
MIND
NCT ID:
NCT01700959
Start Date:
January 2013
Completion Date:
January 2018
Related Keywords:
- Cancer Malignancies
- Melatonin
- Neurocognitive impairment
- Sleep disturbance
- Childhood cancer survivors
- Neoplasms
Name | Location |
|---|---|
| St. Jude Children's Research Hospital | Memphis, Tennessee 38105-2794 |
