Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
Condition: Cancer Malignancies
MeSH terms: Neoplasms
Intervention: melatonin; placebo
Intervention description: 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 tablets to match the melatonin will be comprised of inert substances.
Intervention MeSH terms: Melatonin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 911.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melatonin; Neurocognitive impairment; Sleep disturbance; Childhood cancer survivors

Summary:

      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.
    

Eligibility criteria:

        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