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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Arizona
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Scottsdale, Arizona, Forenede Stater, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Forenede Stater, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Forenede Stater, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Forenede Stater, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Forenede Stater, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Forenede Stater, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Forenede Stater, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Forenede Stater, 67214-3882
- CCOP - Wichita
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic Cancer Center
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Nebraska
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Omaha, Nebraska, Forenede Stater, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Forenede Stater, 58501
- Medcenter One Health System
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Fargo, North Dakota, Forenede Stater, 58122
- CCOP - Merit Care Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15212-4772
- Allegheny General Hospital
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South Dakota
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Rapid City, South Dakota, Forenede Stater, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Forenede Stater, 57104
- CCOP - Sioux Community Cancer Consortium
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
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
Tidsramme: Up to 6 months
|
Up to 6 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Livskvalitet
Tidsramme: Op til 6 måneder
|
Op til 6 måneder
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Adfærdsmæssige symptomer
- Psykiske lidelser
- Sygdomme i nervesystemet
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neurologiske manifestationer
- Forvirring
- Neuroadfærdsmæssige manifestationer
- Neurokognitive lidelser
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Depression
- Delirium
- Lungeneoplasmer
- Småcellet lungekarcinom
- Lægemidlers fysiologiske virkninger
- Neurotransmittermidler
- Molekylære mekanismer for farmakologisk virkning
- Kolinerge midler
- Enzymhæmmere
- Beskyttelsesagenter
- Mikronæringsstoffer
- Vitaminer
- Antioxidanter
- Nootropiske midler
- Cholinesterasehæmmere
- E-vitamin
- Donepezil
Andre undersøgelses-id-numre
- NCCTG-N99C5
- CDR0000068206 (Registry Identifier: PDQ (Physician Data Query))
- NCI-P00-0169
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