The Effect of Donepezil on Sedation and Other Symptoms

NCT00352664 | Terminated Phase 3 Results

• 1 other identifier: 2003-0425
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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. 1.To assess the side-effects in both groups of 1 week treatment of 5 mg donepezil and placebo
2. 2.To assess the effects of donepezil on fatigue (FACIT-Fatigue), and other symptoms (Anderson Symptom Assessment Scale)
3. 3.To assess the effects of donepezil on cognition (Symbol Digit Modalities Test)
4. 4.To assess the effects of donepezil on constipation (number of bowel movements)

Conditions

Advanced Cancer

Keywords

Advanced Cancer; Cancer Pain; Donepezil; Sedation; Placebo

Outcome Measures

Primary Outcomes (1)

• Sedation Mean Scores at 1-Week

  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."

  Baseline and Day 7

Study Arms (2)

Donepezil

ACTIVE COMPARATOR

Oral Donepezil 5 mg daily x 7 days

Drug: Donepezil

daily x 7 days

PLACEBO COMPARATOR

Placebo tablet daily x 7 days

Drug: Placebo

Interventions

Donepezil DRUG

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.

Also known as: Aricept

Donepezil

Placebo DRUG

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.

daily x 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.
• 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.
• 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.
• Sexually active females at risk of being pregnant with a negative urine pregnancy test
• Written consent form signed.
• Patients are 18 years or older
• Concurrent radiation treatment (defined as 10 or less fractions for a palliative indication) is allowed
• Concurrent chemotherapy is allowed, if the first two cycles have been well tolerated (defined as no grade 3 or 4 non-hematological toxicity)

You may not qualify if:

• Major contraindication to donepezil i.e. hypersensitivity to donepezil or piperidine derivatives.
• Patients in whom a major change in opiate dose, analgesia requirements, anesthetic procedures or general anesthetic is expected over the next seven days.
• Treatment with anti-cholinergic agents (i.e., glycopyrrolate)
• Patients taking Methylphenidate.
• Patients with tube feeding (due to difficulty of accurate assessing some of the symptoms such as appetite and anorexia).
• History of ongoing arrhythmia causing a rhythm other than a sinus rhythm

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Cancer Pain

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Insufficient drug supply and low patient accrual closed study early.

Results Point of Contact

• Title: Eduardo Bruera, MD / Professor
• Organization: UT MD Anderson Cancer Center

713-792-6084

Study Officials

• Eduardo Bruera, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 14, 2006
• Study Start: November 1, 2003
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 9, 2016
• Results First Posted: December 29, 2009

Record last verified: 2009-12

Locations

US (1)