- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00006349
Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
An Exploratory Trial of Donepezil and Vitamin E to Prevent Cognitive Dysfunction in Patients With Small Cell Lung Cancer (SCLC) After Cancer Treatment Which Includes Prophylatic Cranial Irradiation (PCI)
RATIONALE: Donepezil and vitamin E may be able to decrease side effects caused by radiation therapy given to prevent brain metastases in patients with small cell lung cancer. It is not yet known if donepezil and vitamin E are effective in preventing side effects caused by radiation therapy to the head.
PURPOSE: Randomized phase III trial to determine the effectiveness of donepezil and vitamin E in preventing side effects caused by radiation therapy given to prevent brain metastases in patients who have small cell lung cancer.
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
OBJECTIVES:
- Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with donepezil and vitamin E vs placebo.
- Determine the toxicity of donepezil and vitamin E in these patients.
- Determine whether preserved cognitive function favorably impacts quality of life in these patients.
- Determine the natural history of cognitive decline in these patients after cancer treatment.
- Determine whether genotypes of apolipoprotein E predict decline in cognitive function among patients at risk for treatment-associated dementia and whether these genotypes predict duration of disease-free survival among patients who have achieved complete response after treatment for SCLC.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to cognitive function (normal vs mild to moderate dysfunction vs severe dysfunction) and age (60 and under vs over 60).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral donepezil daily and vitamin E twice daily.
- Arm II: Patients receive oral placebos according to the same schedule as the study drugs in arm I.
All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale.
Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study.
Quality of life and depression are assessed at baseline and then every 3 months during study.
Patients are followed every 6 months.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Arizona
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Scottsdale, Arizona, Vereinigte Staaten, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Vereinigte Staaten, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Vereinigte Staaten, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Vereinigte Staaten, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Vereinigte Staaten, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Vereinigte Staaten, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Vereinigte Staaten, 67214-3882
- CCOP - Wichita
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Minnesota
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Rochester, Minnesota, Vereinigte Staaten, 55905
- Mayo Clinic Cancer Center
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Nebraska
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Omaha, Nebraska, Vereinigte Staaten, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Vereinigte Staaten, 58501
- Medcenter One Health System
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Fargo, North Dakota, Vereinigte Staaten, 58122
- CCOP - Merit Care Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15212-4772
- Allegheny General Hospital
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South Dakota
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Rapid City, South Dakota, Vereinigte Staaten, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Vereinigte Staaten, 57104
- CCOP - Sioux Community Cancer Consortium
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
DISEASE CHARACTERISTICS:
Diagnosis of small cell lung cancer (SCLC)
Must meet one of the following conditions:
- Enrolled no more than 4 weeks before initiation of prophylactic cranial irradiation (PCI) OR
- Enrolled no more than 10 days after initiation of PCI
- Limited or extensive stage SCLC with complete response (CR) outside chest allowed
- Must have CR or minimal disease after completion of intended course of chemotherapy
- No disease progression since initiation of PCI
- No prior or concurrent CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
Renal:
- Creatinine no greater than 2 times upper limit of normal
Cardiovascular:
- No sick sinus syndrome or other symptomatic supraventricular conduction disorders even if symptoms currently controlled by antiarrhythmics
Pulmonary:
- No history of asthma or chronic obstructive pulmonary disease requiring chronic oxygen therapy
Other:
- No medical or psychiatric condition that would increase risk
- No seizure disorder
- No ongoing alcohol abuse
PRIOR CONCURRENT THERAPY:
Chemotherapy:
- See Disease Characteristics
- No concurrent anticancer chemotherapy
Other:
- No concurrent medications that would impair baseline cognitive function or are likely to be dose escalated over the next few months
- No other concurrent vitamin E
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: donepezil + vitamin E
Patients receive oral donepezil daily and vitamin E twice daily. All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale. Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study. Quality of life and depression are assessed at baseline and then every 3 months during study. Patients are followed every 6 months. |
|
Placebo-Komparator: placebo
Patients receive oral placebo twice daily. All patients begin treatment within 2 weeks after completion of prophylactic cranial irradiation. Treatment continues for a minimum of 1 month in the absence of disease progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination (MMSE) and/or a 5 point drop on the Blessed Dementia Scale. Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then every 3 months during study. Quality of life and depression are assessed at baseline and then every 3 months during study. Patients are followed every 6 months. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Compare the interval between completion of cancer treatment that included prophylactic cranial irradiation and onset of cognitive decline in patients with small cell lung cancer (SCLC) treated with donepezil and vitamin E vs placebo
Zeitfenster: Up to 6 months
|
Up to 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Lebensqualität
Zeitfenster: Bis zu 6 Monaten
|
Bis zu 6 Monaten
|
Mitarbeiter und Ermittler
Mitarbeiter
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Verhaltenssymptome
- Psychische Störungen
- Erkrankungen des Nervensystems
- Erkrankungen der Atemwege
- Neubildungen
- Lungenkrankheit
- Neubildungen nach Standort
- Neurologische Manifestationen
- Verwirrtheit
- Neurobehaviorale Manifestationen
- Neurokognitive Störungen
- Neubildungen der Atemwege
- Thoraxneoplasmen
- Karzinom, bronchogen
- Bronchiale Neubildungen
- Depression
- Delirium
- Lungentumoren
- Kleinzelliges Lungenkarzinom
- Physiologische Wirkungen von Arzneimitteln
- Neurotransmitter-Agenten
- Molekulare Mechanismen der pharmakologischen Wirkung
- Cholinerge Wirkstoffe
- Enzym-Inhibitoren
- Schutzmittel
- Mikronährstoffe
- Vitamine
- Antioxidantien
- Nootropische Wirkstoffe
- Cholinesterase-Hemmer
- Vitamin E
- Donepezil
Andere Studien-ID-Nummern
- NCCTG-N99C5
- CDR0000068206 (Registrierungskennung: PDQ (Physician Data Query))
- NCI-P00-0169
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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