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Donepezil for Cancer Patients With Sedation Related to Opioid Treatment: A Double-blind Placebo Controlled Randomized Study


Phase 3
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

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Trial Information

Donepezil for Cancer Patients With Sedation Related to Opioid Treatment: A Double-blind Placebo Controlled Randomized Study


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.


Inclusion Criteria:



1. Patient with drowsiness/sedation caused by opiate for > 3 days and its intensity more
or equal to 3/10 (0 to 10 scale; 0 = no sedation, 10=worst possible sedation).

2. Patient receiving a regular dose of a strong opioid for the treatment of cancer pain,
and no dose changes or dose change within 50% for at least 48 hours.Regular
administration, defined as short acting opioids oral or parenteral every 4 hours
around clock, slow release oral opioids every 12 hs or 24 hs, or transdermal opioids
every 72 hours. Strong opioids include morphine, hydromorphone, methadone, fentanyl,
and oxycodone.

3. Patient with relatively intact cognition defined by the Mini Mental State Examination
according to age and educational level. A score of 24 or above is usually considered
normal.

4. Patient willing to engage in follow up visit with a nurse by phone on day 2-7 (each
day), 11 and 15 of the study and to return for follow up visit on day 8 of treatment.
If patient is unable to come to clinic, assessment will be performed through
telephone.

5. Sexually active females at risk of being pregnant with a negative urine pregnancy
test

6. Written consent form signed.

7. Patients are 18 years or older

8. Concurrent radiation treatment (defined as 10 or less fractions for a palliative
indication) is allowed

9. Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated
(defined as no grade 3 or 4 non-hematological toxicity)

Exclusion Criteria:

1. Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine
derivatives.

2. Patients in whom a major change in opiate dose, analgesia requirements, anesthetic
procedures or general anesthetic is expected over the next seven days.

3. Treatment with anti-cholinergic agents (i.e., glycopyrrolate)

4. Patients taking Methylphenidate.

5. Patients with tube feeding (due to difficulty of accurate assessing some of the
symptoms such as appetite and anorexia).

6. History of ongoing arrhythmia causing a rhythm other than a sinus rhythm

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Sedation Mean Scores at 1-Week

Outcome Time Frame:

Baseline and Day 7

Safety Issue:

No

Principal Investigator

Eduardo Bruera, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2003-0425

NCT ID:

NCT00352664

Start Date:

November 2003

Completion Date:

July 2007

Related Keywords:

  • Advanced Cancer
  • Advanced Cancer
  • Cancer Pain
  • Donepezil
  • Sedation
  • Placebo
  • Neoplasms

Name

Location

U.T. M.D. Anderson Cancer CenterHouston, Texas  77030