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

• Status: Completed
• Trial end date: 2017-04-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Melatonin

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