drugset / Trial / NCT01700959
Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
Phase 3
Completed
911 enrolled
St. Jude Children's Research Hospital
National Cancer Institute (NCI) · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2013-02-06
- Primary completion
- 2017-04-19
- Completion
- 2017-04-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Melatonin | Small molecule | 3 mg | Oral |