- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00337272
Treating Chronic Insomnia in Breast Cancer Patients
18. srpna 2011 aktualizováno: Accelerated Community Oncology Research Network
Phase IV: Treatment of Chronic Insomnia in Patients With Breast Cancer Following Completion of Chemotherapy
This study is being conducted to evaluate the effectiveness of ramelteon 8mgs in the treatment of insomnia in patients that have completed their first chemotherapy treatment for breast cancer.
Přehled studie
Detailní popis
Phase IV, randomized, double-blind, placebo-controlled, parallel-group study to assess the efficacy of ramelteon 8mgs in the treatment of insomnia in patients with breast cancer.
Typ studie
Intervenční
Zápis (Aktuální)
16
Fáze
- Fáze 4
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Arkansas
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Hot Springs, Arkansas, Spojené státy, 71913
- Genesis Cancer Center
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California
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La Verne, California, Spojené státy, 91750
- Wilshire Oncology Medical Group, Inc.
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Connecticut
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Norwich, Connecticut, Spojené státy, 06360
- Eastern Connecticut Hematology and Oncology Associates
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Georgia
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Augusta, Georgia, Spojené státy, 30901
- Augusta Oncology Associates, PC
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Idaho
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Coeur d'Alene, Idaho, Spojené státy, 83814
- North Idaho Cancer Center
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Montana
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Billings, Montana, Spojené státy, 59101
- Hematology Oncology Centers of the Northern Rockies
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Ohio
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Canton, Ohio, Spojené státy, 44718
- Tri-County Hematology & Oncology Associates
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Pennsylvania
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Pottsville, Pennsylvania, Spojené státy, 17901
- Pottsville Cancer Center
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Tennessee
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Memphis, Tennessee, Spojené státy, 38120
- The West Clinic
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Virginia
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Chesapeake, Virginia, Spojené státy, 23320
- Cancer Specialists of Tidewater, Ltd.
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
21 let až 60 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- Female patients aged 21-60 years old
- Have a negative serum or urine pregnancy test for women of child-bearing potential
- Have a three-month or longer history of insomnia
- Self-report < 6.5 hours of total sleep time, in addition to a sleep efficiency of less than 85%, averaged over two weeks of screening
- A score of less than 60 on the Zung Self-Rating Depression Scale
- Self-report bedtimes that do not vary by more than two hours on five nights per week
- Have completed chemotherapy for breast cancer less than two years prior to study drug administration
- Have completed chemotherapy for breast cancer for at least two months prior to screening visit
- Patients that are receiving Herceptin are eligible for study enrollment
- Have completed radiation therapy for breast cancer for at least two months prior to screening visit
- ECOG (Eastern Cooperative Oncology Group)score of 0-1
- Be able to read, understand, and provide written informed consent before enrolling in the study
- Must be willing to comply with all study visits and comply with daily phone calls to the IVRS throughout the study
- Agree to participate for the entire study period (about two months)
Exclusion Criteria:
- Metastatic disease
- Pregnant or lactating female
- Self-reports typical consumption of more than five alcoholic beverages on a single day or greater than 14 alcoholic beverages weekly
- Self-reports use of products containing nicotine of greater than 15 cigarettes daily or cannot avoid products containing nicotine during sleep periods
- Current use of any of the following medications, and cannot discontinue these medications for the duration of the study: Hypnotic medication, Anti-convulsants, Anxiolytics, Narcotic analgesics, Medications or supplements containing Melatonin, Ketaconazole and Fluconazole
- Currently taking fluvoxamine, brand name Luvox
- Have symptoms consistent with the diagnosis of any other sleep disorder other than insomnia (e.g. obstructive sleep apnea, narcolepsy, restless legs syndrome)
- Currently on night or rotating shift work
- Self-reports habitual napping of greater than one hour accumulated sleep on 4 or more days per week
- Has a psychiatric illness that interferes with normal sleep-wake function (e.g. major depression, post-traumatic stress disorder)
- A score of 60 or greater on the Zung Self-Rating Depression Scale
- Has current unstable medical disorder, such as symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, or other serious medical condition as determined by the Investigator
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Komparátor placeba: 1 (Placebo)
Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
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Placebo taken 30 minutes before bedtime days 1-28 of treatment period
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Aktivní komparátor: 2 (Ramelteon)
Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
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8 mgs daily for days 1-28 of treatment period
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Sleep Efficiency
Časové okno: Every morning during the screening, treatment, and withdrawal periods
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Total time in bed is calculated as the time the subject got out of bed minus the time the subject went to bed.
The total sleep time is reported by the subject.
Percent sleep efficiency is calulated as 100*(total sleep time divided by total time in bed).
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Every morning during the screening, treatment, and withdrawal periods
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Quantitative Sleep Parameters - Total Sleep Time
Časové okno: Every morning during the screening, treatment, and withdrawal periods
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The subject reports how many hours of sleep she got.
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Every morning during the screening, treatment, and withdrawal periods
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Quantitative Sleep Parameters - Number of Awakenings
Časové okno: Every morning during the screening, treatment, and withdrawal periods
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The subject reports how many times she woke up during the night.
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Every morning during the screening, treatment, and withdrawal periods
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Qualitative Evaluation of Sleep - Global Sleep Impression
Časové okno: Once during the withdrawal period
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The Patient Global Impression is a 7-point scale which asks "How much has your sleep improved?"
with the following anchors: no improvement, minimal improvement, slight improvement, moderate improvement, very good improvement, near complete improvement, and complete improvement.
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Once during the withdrawal period
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Qualitative Evaluation of Sleep - Quality of Sleep
Časové okno: Every morning during the screening, treatment, and withdrawal periods
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The subject rates the quality of her sleep on a scale of 0 through 10, where 0 is a very bad night of sleep and 10 is a very good night of sleep.
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Every morning during the screening, treatment, and withdrawal periods
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Daytime Function - Fatigue
Časové okno: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
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The subject rates her fatigue on a scale of 0 through 10, where 0 is not a problem and 10 is as bad as possible.
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Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
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Daytime Function - Despair
Časové okno: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
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The subject rates 7 questions related to despair on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible.
The scores of these 7 questions are combined and normalized, and used to describe despair.
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Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
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Daytime Function - Distress
Časové okno: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
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The subject rates 4 questions related to distress on a scale of 0 through 10 for each question, where 0 is not bad and 10 is as bad as possible.
The scores of these 4 questions are combined and normalized, and used to describe distress.
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Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Studijní židle: Edward J. Stepanski, Ph.D., Accelerated Community Oncology Research Network
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. srpna 2006
Primární dokončení (Aktuální)
1. srpna 2008
Dokončení studie (Aktuální)
1. ledna 2009
Termíny zápisu do studia
První předloženo
13. června 2006
První předloženo, které splnilo kritéria kontroly kvality
13. června 2006
První zveřejněno (Odhad)
15. června 2006
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
22. srpna 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. srpna 2011
Naposledy ověřeno
1. srpna 2011
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ACORN AEJSINS0601
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .