Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 911
- 试验地点
- 1
- 主要终点
- Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
研究概览
简要总结
Primary objective:
- To examine the efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer.
Secondary objectives:
- To evaluate the efficacy of melatonin treatment on delayed sleep onset latency in long-term childhood cancer survivors.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >
- •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
排除标准
- •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
研究组 & 干预措施
Melatonin
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
干预措施: melatonin (Drug)
Placebo
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
干预措施: placebo (Drug)
结局指标
主要结局
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
时间窗: Baseline and 6 months after start of therapy
Efficacy of melatonin treatment on neurocognitive functioning in adult survivors of childhood cancer (Cohorts 1 and 2 only). The measures were analyzed to compare change in neurocognitive performance from baseline to 6 months between active treatment and placebo groups. The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1. A higher z-score represents a better outcome.
次要结局
- Sleep Onset Latency as Measured by Actigraphy and Self-report.(Baseline and six months after start of therapy)
- Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function, and Sleep Onset Latency as Measured by Actigraphy and Self-report.(Baseline and six months after start of therapy)