Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352664
Status:
TERMINATED
Last Update Posted:
2016-05-09
First Post:
2006-07-12
Brief Title:
The Effect of Donepezil on Sedation and Other Symptoms
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Donepezil for Cancer Patients With Sedation Related to Opioid Treatment A Double-blind Placebo Controlled Randomized Study
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low patient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
1 To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedationdrowsiness in patients with stable cancer pain
Secondary Objectives
1 To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo
2 To assess the effects of donepezil on fatigue FACIT-Fatigue and other symptoms Anderson Symptom Assessment Scale
3 To assess the effects of donepezil on cognition Symbol Digit Modalities Test
4 To assess the effects of donepezil on constipation number of bowel movements
1 To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedationdrowsiness in patients with stable cancer pain
Secondary Objectives
1 To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo
2 To assess the effects of donepezil on fatigue FACIT-Fatigue and other symptoms Anderson Symptom Assessment Scale
3 To assess the effects of donepezil on cognition Symbol Digit Modalities Test
4 To assess the effects of donepezil on constipation number of bowel movements
Detailed Description:
Donepezil is currently used in the treatment of certain types of mental disorders including Alzheimers disease Recent research studies have shown that donepezil helps to improve drowsiness in cancer patients receiving opioid medication
Before treatment starts you will be asked to answer some questions regarding your cancer diagnosis the medication you are taking and the symptoms you are having ie pain fatigue nausea depression anxiety drowsiness shortness of breath appetite sleep problem constipation and well-being and a test for your cognitive status matching specific numbers with given geometric figures will be performed It will take about 30 minutes to complete the evaluation Women who are at risk of being pregnant must have a negative urine pregnancy test
If you are qualified to enter the study you will be randomly assigned as in the toss of a coin to one of two groups Participants in one group will receive donepezil for one week Participants in the other group will receive a placebo a tablet that does not contain any medication but looks just like the donepezil pill You will have an equal chance 5050 of being placed in either group Neither you nor any the medical staff or researchers on this study will know if you are receiving the study drug or the placebo
You will take 1 tablet of donepezilplacebo a day for 7 days The research nurse will contact you by phone in person if you are in the hospital daily to ask questions about side effects and other symptoms
On Day 8 you will need to come to the palliative care clinic for an evaluation If you can not come to clinic on day 8 evaluation will be performed through telephone Evaluation of sedationdrowsiness pain constipation fatigue side effects effectiveness of the treatment and a test of nervous system and cognitive status will be performed If you develop intolerable side effects while on this study the medication will be stopped and you will be removed from the study
After evaluation on Day 8 all participants will be offered the chance to receive 1 tablet of donepezil every day for 7 days The research nurse will follow up with you by phone in person if you are in the hospital 3 or 4 days after you received donepezil open label to ask questions about side effects and other symptoms
On Day 15 you will need to come to the palliative care clinic for an evaluation Evaluation of sedationdrowsiness pain constipation fatigue side effects effectiveness of the treatment and a test of nervous system and cognitive status will be performed You will be given an option to continue on an additional 8 weeks During these 8 weeks the follow up will be conducted by your primary physician
This is an investigational study Donepezil has been approved by FDA and is a commercially available drug Its use in this study is investigational It can continue to be prescribed by your primary physician after that time if needed A total of 100 patients will take part in this study All will be enrolled at M D Anderson
Before treatment starts you will be asked to answer some questions regarding your cancer diagnosis the medication you are taking and the symptoms you are having ie pain fatigue nausea depression anxiety drowsiness shortness of breath appetite sleep problem constipation and well-being and a test for your cognitive status matching specific numbers with given geometric figures will be performed It will take about 30 minutes to complete the evaluation Women who are at risk of being pregnant must have a negative urine pregnancy test
If you are qualified to enter the study you will be randomly assigned as in the toss of a coin to one of two groups Participants in one group will receive donepezil for one week Participants in the other group will receive a placebo a tablet that does not contain any medication but looks just like the donepezil pill You will have an equal chance 5050 of being placed in either group Neither you nor any the medical staff or researchers on this study will know if you are receiving the study drug or the placebo
You will take 1 tablet of donepezilplacebo a day for 7 days The research nurse will contact you by phone in person if you are in the hospital daily to ask questions about side effects and other symptoms
On Day 8 you will need to come to the palliative care clinic for an evaluation If you can not come to clinic on day 8 evaluation will be performed through telephone Evaluation of sedationdrowsiness pain constipation fatigue side effects effectiveness of the treatment and a test of nervous system and cognitive status will be performed If you develop intolerable side effects while on this study the medication will be stopped and you will be removed from the study
After evaluation on Day 8 all participants will be offered the chance to receive 1 tablet of donepezil every day for 7 days The research nurse will follow up with you by phone in person if you are in the hospital 3 or 4 days after you received donepezil open label to ask questions about side effects and other symptoms
On Day 15 you will need to come to the palliative care clinic for an evaluation Evaluation of sedationdrowsiness pain constipation fatigue side effects effectiveness of the treatment and a test of nervous system and cognitive status will be performed You will be given an option to continue on an additional 8 weeks During these 8 weeks the follow up will be conducted by your primary physician
This is an investigational study Donepezil has been approved by FDA and is a commercially available drug Its use in this study is investigational It can continue to be prescribed by your primary physician after that time if needed A total of 100 patients will take part in this study All will be enrolled at M D Anderson
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