Treating Chronic Insomnia in Breast Cancer Patients
18. August 2011 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
16
Phase
- Phase 4
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Arkansas
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Hot Springs, Arkansas, Vereinigte Staaten, 71913
- Genesis Cancer Center
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California
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La Verne, California, Vereinigte Staaten, 91750
- Wilshire Oncology Medical Group, Inc.
-
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Connecticut
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Norwich, Connecticut, Vereinigte Staaten, 06360
- Eastern Connecticut Hematology and Oncology Associates
-
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Georgia
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Augusta, Georgia, Vereinigte Staaten, 30901
- Augusta Oncology Associates, PC
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Idaho
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Coeur d'Alene, Idaho, Vereinigte Staaten, 83814
- North Idaho Cancer Center
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Montana
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Billings, Montana, Vereinigte Staaten, 59101
- Hematology Oncology Centers of the Northern Rockies
-
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Ohio
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Canton, Ohio, Vereinigte Staaten, 44718
- Tri-County Hematology & Oncology Associates
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Pennsylvania
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Pottsville, Pennsylvania, Vereinigte Staaten, 17901
- Pottsville Cancer Center
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Tennessee
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Memphis, Tennessee, Vereinigte Staaten, 38120
- The West Clinic
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Virginia
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Chesapeake, Virginia, Vereinigte Staaten, 23320
- Cancer Specialists of Tidewater, Ltd.
-
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: 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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Aktiver Komparator: 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
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Sleep Efficiency
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Quantitative Sleep Parameters - Total Sleep Time
Zeitfenster: 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
Zeitfenster: 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
|
|
Qualitative Evaluation of Sleep - Global Sleep Impression
Zeitfenster: Once during the withdrawal period
|
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
|
|
Qualitative Evaluation of Sleep - Quality of Sleep
Zeitfenster: 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
|
|
Daytime Function - Fatigue
Zeitfenster: 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
Zeitfenster: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
|
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
Zeitfenster: Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
|
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.
|
Once during the screening period; once during the treatment period; twice during the withdrawal period for a total of 4 assessments
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Studienstuhl: Edward J. Stepanski, Ph.D., Accelerated Community Oncology Research Network
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2006
Primärer Abschluss (Tatsächlich)
1. August 2008
Studienabschluss (Tatsächlich)
1. Januar 2009
Studienanmeldedaten
Zuerst eingereicht
13. Juni 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. Juni 2006
Zuerst gepostet (Schätzen)
15. Juni 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
22. August 2011
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
18. August 2011
Zuletzt verifiziert
1. August 2011
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- ACORN AEJSINS0601
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