The Effect of Donepezil on Sedation and Other Symptoms

NCT00352664

Last updated date
Study Location
U.T. M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Advanced CancerThe Effect of Donepezil on Sedation and Other Symptoms
NCT00352664
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced CancerClinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer
NCT01347866
  1. Los Angeles, California
  2. Los Angeles, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Santa Monica, California
  6. Santa Monica, California
  7. Aurora, Colorado
  8. Aurora, Colorado
  9. Aurora, Colorado
  10. Aurora, Colorado
  11. Charleston, South Carolina
  12. Charleston, South Carolina
  13. Charleston, South Carolina
  14. Mount Pleasant, South Carolina
  15. North Charleston, South Carolina
  16. Toronto, Ontario
  17. Milano,
  18. Barcelona,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced CancerA Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley)
NCT02554812
  1. La Jolla, California
  2. La Jolla, California
  3. Clinton, North Carolina
  4. Goldsboro, North Carolina
  5. Jacksonville, North Carolina
  6. Encinitas, California
  7. La Jolla, California
  8. La Jolla, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. San Diego, California
  14. Vista, California
  15. Washington, District of Columbia
  16. Aventura, Florida
  17. Miami Beach, Florida
  18. Sarasota, Florida
  19. Tampa, Florida
  20. Iowa City, Iowa
  21. Ann Arbor, Michigan
  22. Ann Arbor, Michigan
  23. Detroit, Michigan
  24. Detroit, Michigan
  25. Farmington Hills, Michigan
  26. Northville, Michigan
  27. New York, New York
  28. New York, New York
  29. New York, New York
  30. New York, New York
  31. New York, New York
  32. New York, New York
  33. New York, New York
  34. New York, New York
  35. Clinton, North Carolina
  36. Goldsboro, North Carolina
  37. Jacksonville, North Carolina
  38. Philadelphia, Pennsylvania
  39. Providence, Rhode Island
  40. Providence, Rhode Island
  41. Sioux Falls, South Dakota
  42. Sioux Falls, South Dakota
  43. Sioux Falls, South Dakota
  44. Sioux Falls, South Dakota
  45. Nashville, Tennessee
  46. Nashville, Tennessee
  47. Nashville, Tennessee
  48. Nashville, Tennessee
  49. Dallas, Texas
  50. Dallas, Texas
  51. Houston, Texas
  52. Seattle, Washington
  53. Seattle, Washington
  54. Camperdown, New South Wales
  55. Macquarie University, New South Wales
  56. Macquarie University, New South Wales
  57. North Sydney, New South Wales
  58. North Sydney, New South Wales
  59. Old Toongabie, New South Wales
  60. Brighton, Victoria
  61. Brighton, Victoria
  62. Heidelberg, Victoria
  63. Malvern, Victoria
  64. Malvern, Victoria
  65. Malvern, Victoria
  66. Malvern, Victoria
  67. New South Wales,
  68. New South Wales,
  69. Edmonton, Alberta
  70. Vancouver, British Columbia
  71. Ottawa, Ontario
  72. Toronto, Ontario
  73. Montreal, Quebec
  74. Montreal, Quebec
  75. Villejuif, Cedex
  76. Villejuif,
  77. Kashiwa, Chiba
  78. Chuo-ku, Tokyo
  79. Warszawa, Mazowieckie
  80. Poznan, Wielkopolskie
  81. Poznan, Wielkopolskie
  82. Poznan, Wielkopolskie
  83. Poznan, Wielkopolskie
  84. Taipei,
  85. Taipei,
  86. London,
  87. London,
  88. London,
  89. London,
  90. London,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced CancerHepatic Impairment Study For Crizotinib In Advanced Cancer Patients
NCT01576406
  1. Los Angeles, California
  2. Los Angeles, California
  3. Los Angeles, California
  4. Los Angeles, California
  5. Aurora, Colorado
  6. Aurora, Colorado
  7. Aurora, Colorado
  8. Aurora, Colorado
  9. Atlanta, Georgia
  10. Atlanta, Georgia
  11. Atlanta, Georgia
  12. Atlanta, Georgia
  13. Atlanta, Georgia
  14. Columbus, Ohio
  15. Columbus, Ohio
  16. Columbus, Ohio
  17. Columbus, Ohio
  18. Columbus, Ohio
  19. San Antonio, Texas
  20. San Antonio, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE The Effect of Donepezil on Sedation and Other Symptoms
Official Title  ICMJE Donepezil for Cancer Patients With Sedation Related to Opioid Treatment: A Double-blind Placebo Controlled Randomized Study
Brief Summary

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)
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Drug: Donepezil
    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
  • Drug: Placebo
    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.
Study Arms  ICMJE
  • Active Comparator: Donepezil
    Oral Donepezil 5 mg daily x 7 days
    Intervention: Drug: Donepezil
  • Placebo Comparator: daily x 7 days
    Placebo tablet daily x 7 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 23, 2009)
27
Original Enrollment  ICMJE
 (submitted: July 12, 2006)
100
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00352664
Other Study ID Numbers  ICMJE 2003-0425
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eduardo Bruera, MD / Professor, UT MD Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Eduardo Bruera, MDM.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP