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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Arizona
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Scottsdale, Arizona, Stati Uniti, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Stati Uniti, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Stati Uniti, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Stati Uniti, 61801
- CCOP - Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Stati Uniti, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Stati Uniti, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Stati Uniti, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Stati Uniti, 67214-3882
- CCOP - Wichita
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Minnesota
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Rochester, Minnesota, Stati Uniti, 55905
- Mayo Clinic Cancer Center
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Stati Uniti, 58501
- Medcenter One Health System
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Fargo, North Dakota, Stati Uniti, 58122
- CCOP - Merit Care Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15212-4772
- Allegheny General Hospital
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South Dakota
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Rapid City, South Dakota, Stati Uniti, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Stati Uniti, 57104
- CCOP - Sioux Community Cancer Consortium
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
|
Comparatore placebo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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
Lasso di tempo: Up to 6 months
|
Up to 6 months
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Qualità della vita
Lasso di tempo: Fino a 6 mesi
|
Fino a 6 mesi
|
Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Sintomi comportamentali
- Disordini mentali
- Malattie del sistema nervoso
- Malattie delle vie respiratorie
- Neoplasie
- Malattie polmonari
- Neoplasie per sede
- Manifestazioni neurologiche
- Confusione
- Manifestazioni neurocomportamentali
- Disturbi neurocognitivi
- Neoplasie delle vie respiratorie
- Neoplasie toraciche
- Carcinoma, broncogeno
- Neoplasie bronchiali
- Depressione
- Delirio
- Neoplasie polmonari
- Carcinoma polmonare a piccole cellule
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti colinergici
- Inibitori enzimatici
- Agenti protettivi
- Micronutrienti
- Vitamine
- Antiossidanti
- Agenti nootropi
- Inibitori della colinesterasi
- Vitamina E
- Donepezil
Altri numeri di identificazione dello studio
- NCCTG-N99C5
- CDR0000068206 (Identificatore di registro: PDQ (Physician Data Query))
- NCI-P00-0169
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