Advanced Cancer Clinical Trial
Official title:
Donepezil for Cancer Patients With Sedation Related to Opioid Treatment: A Double-blind Placebo Controlled Randomized Study
Primary Objective:
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
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)
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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