The Effect of Donepezil on Sedation and Other Symptoms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00352664|
Recruitment Status : Terminated (Low patient accrual)
First Posted : July 14, 2006
Results First Posted : December 29, 2009
Last Update Posted : May 9, 2016
1. To determine the effectiveness of donepezil as compared to placebo for the management of opiate-induced sedation/drowsiness in patients with stable cancer pain
- To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo
- To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms (Anderson Symptom Assessment Scale)
- To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)
- To assess the effects of donepezil on constipation (number of bowel movements)
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: Donepezil Drug: Placebo||Phase 3|
Donepezil is currently used in the treatment of certain types of mental disorders, including Alzheimer's 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 (i.e. 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 (50/50) 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 donepezil/placebo 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 sedation/drowsiness, 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 sedation/drowsiness, 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Donepezil for Cancer Patients With Sedation Related to Opioid Treatment: A Double-blind Placebo Controlled Randomized Study|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Active Comparator: Donepezil
Oral Donepezil 5 mg daily x 7 days
5 mg once a day by mouth for 7 day cycle. After evaluation on Day 8, all participants will be offered donepezil every day for 7 days.
Other Name: Aricept
Placebo Comparator: daily x 7 days
Placebo tablet daily x 7 days
Placebo tablet once a day by mouth for one 7 day cycle. After evaluation on day 8, all participants offered donepezil every day for 7 days.
- Sedation Mean Scores at 1-Week [ Time Frame: Baseline and Day 7 ]Anderson Symptom Assessment Scale (ASAS) was used to measure sedation mean scores (SD) on a 0-10 scale with 0 representing "not drowsy" and 10 representing "worst possible drowsiness."
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00352664
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eduardo Bruera, MD||M.D. Anderson Cancer Center|