At a glance
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Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
In Brief
A Phase 3 clinical trial evaluating melatonin and placebo for Cancer Malignancies. Completed, enrolled 911 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.