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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Cancer Malignancies

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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 HospitalMemphis, Tennessee  38105-2794