Melatonin Intervention For Neurocognitive Deficits in the St. Jude Lifetime Cohort
2018年6月26日 更新者：St. Jude Children's Research Hospital
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.
調査の概要
詳細な説明
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.
Psychosocial measures of health-related quality of life and psychological distress will be completed at baseline and following 6 months of melatonin/placebo treatment.
Biological samples for serum melatonin levels will be collected at baseline and at the 6 month follow-up evaluation.
研究の種類
介入
入学 (実際)
911
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Melatonin
Participants receive 3 mgs of time-release melatonin 1-2 hours prior to bedtime.
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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.
他の名前：
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プラセボコンパレーター：Placebo
Participants receive a placebo identical to the time-release melatonin and are instructed to take it 1-2 hours prior to bedtime.
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Placebo tablets to match the melatonin will be comprised of inert substances.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neurocognitive Function as Measured by Performance on Standardized Tests of Attention, Memory, and Executive Function.
時間枠：Baseline and 6 months after start of therapy
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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.
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Baseline and 6 months after start of therapy
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep Onset Latency as Measured by Actigraphy and Self-report.
時間枠：Baseline and six months after start of therapy
|
Efficacy of melatonin on delayed sleep onset latency in long-term childhood cancer survivors (Cohorts 2 and 3 only).
The measures were analyzed to compare change in sleep onset latency from baseline to 6 months between active treatment and placebo groups.
|
Baseline and six months after start of therapy
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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.
時間枠：Baseline and six months after start of therapy
|
Investigate whether improvement in sleep onset latency due to melatonin treatment is associated with neurocognitive improvement in long-term childhood cancer survivors (Cohort 2).
The change in neurocognitive performance from baseline to 6 months will be examined in relation to change in sleep onset latency.
The unit of measure is a standardized z-score with a mean of 0 and standard deviation of 1.
The unit of measurement is a correlation coefficient (Pearson's R2).
The range is from -1.0 to 1.0.
A zero indicates no correlation while values closer to -1.0 or 1.0 reflect a stronger association.
A negative correlation suggests that as sleep latency decreased, neurocognitive functioning improved.
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Baseline and six months after start of therapy
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Tara Brinkman, PhD、St. Jude Children's Research Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年2月6日
一次修了 (実際)
2017年4月19日
研究の完了 (実際)
2017年4月19日
試験登録日
最初に提出
2012年9月25日
QC基準を満たした最初の提出物
2012年10月2日
最初の投稿 (見積もり)
2012年10月4日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月28日
QC基準を満たした最後の更新が送信されました
2018年6月26日
最終確認日
2018年3月1日
詳しくは
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