Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006349
Status:
COMPLETED
Last Update Posted:
2016-07-13
First Post:
2000-10-04
Brief Title:
Donepezil and Vitamin E to Prevent Side Effects Caused By Radiation Therapy to the Head in Patients Receiving Treatment for Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 30 point drop on the Mini Mental State Examination MMSE andor 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
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 30 point drop on the Mini Mental State Examination MMSE andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068206 | REGISTRY | None | None |
| NCI-P00-0169 | Registry Identifier | PDQ Physician Data Query | None |