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Trial record 69 of 331 for:    DONEPEZIL

Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction

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ClinicalTrials.gov Identifier: NCT01466270
Recruitment Status : Completed
First Posted : November 7, 2011
Results First Posted : January 9, 2015
Last Update Posted : August 9, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Anxiety Disorder
Breast Cancer
Cognition Disorders
Depression
Fatigue
Sleep Disorders
Interventions Drug: donepezil hydrochloride
Drug: Placebo
Enrollment 62
Recruitment Details Patients were accrued between 7/12 and 1/13 from CCOP sites across the nation.
Pre-assignment Details No wash-out or run-in period. All enrolled patients were randomized.
Arm/Group Title Arm I - Donepezil Arm II - Placebo
Hide Arm/Group Description Patients receive donepezil hydrochloride PO QD. Patients receive placebo PO QD.
Period Title: Overall Study
Started 31 31
Completed 19 25
Not Completed 12 6
Reason Not Completed
Withdrawal by Subject             4             1
Physician Decision             1             0
Lost to Follow-up             1             3
Progression             1             0
Toxicity             4             1
Multiple             1             1
Arm/Group Title Arm I - Donepezil Arm II - Placebo Total
Hide Arm/Group Description Patients receive donepezil hydrochloride PO QD. Patients receive placebo PO QD. Total of all reporting groups
Overall Number of Baseline Participants 31 31 62
Hide Baseline Analysis Population Description
All randomized patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
24
  77.4%
27
  87.1%
51
  82.3%
>=65 years
7
  22.6%
4
  12.9%
11
  17.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 31 participants 62 participants
56
(39 to 79)
56
(41 to 78)
56
(39 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Female
31
 100.0%
31
 100.0%
62
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
31
 100.0%
31
 100.0%
62
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 31 participants 62 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  12.9%
1
   3.2%
5
   8.1%
White
27
  87.1%
29
  93.5%
56
  90.3%
More than one race
0
   0.0%
1
   3.2%
1
   1.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 31 participants 62 participants
31 31 62
1.Primary Outcome
Title Retention
Hide Description Retention is the percentage of participants who stay in the study for 24 weeks.
Time Frame 24 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Arm I Arm II
Hide Arm/Group Description:

Patients receive donepezil hydrochloride PO QD.

donepezil hydrochloride: Given PO

Patients receive placebo PO QD.

Placebo: Given PO

Overall Number of Participants Analyzed 31 31
Mean (Standard Error)
Unit of Measure: percentage of participants
71.0  (8.3) 80.7  (7.2)
2.Primary Outcome
Title Compliance
Hide Description Compliance is the percentage of pills taken while on study (based on returned diaries)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who returned pill diaries. Note that some participants did not return diaries so the numbers of participants for this analysis may not agree with the numbers for other analyses.
Arm/Group Title Arm I - Donepezil Arm II - Placebo
Hide Arm/Group Description:
Patients receive donepezil hydrochloride PO QD.
Patients receive placebo PO QD.
Overall Number of Participants Analyzed 26 27
Mean (Full Range)
Unit of Measure: percentage of pills
98.0
(89.6 to 100.0)
98.0
(89.6 to 100.0)
3.Secondary Outcome
Title HVLT-IR
Hide Description Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants except two who did not provide any data.
Arm/Group Title Arm I - Donepezil Arm II - Placebo
Hide Arm/Group Description:
Patients receive donepezil hydrochloride PO QD.
Patients receive placebo PO QD.
Overall Number of Participants Analyzed 30 30
Least Squares Mean (Standard Error)
Unit of Measure: number of words recalled
25.58  (1.36) 22.94  (1.24)
4.Secondary Outcome
Title Fatigue
Hide Description Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants except two who did not provide any data.
Arm/Group Title Arm I - Donepezil Arm II - Placebo
Hide Arm/Group Description:
Patients receive donepezil hydrochloride PO QD.
Patients receive placebo PO QD.
Overall Number of Participants Analyzed 30 30
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
35.89  (2.20) 35.51  (2.02)
Time Frame 40 weeks (one month following the end of the study)
Adverse Event Reporting Description The numbers of participants for this analysis may not agree with the numbers for the other analyses as not all participants completed their AE/toxicity evaluations.
 
Arm/Group Title Arm I - Donepezil Arm II - Placebo
Hide Arm/Group Description Patients receive donepezil hydrochloride PO QD. Patients receive placebo PO QD.
All-Cause Mortality
Arm I - Donepezil Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - Donepezil Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/28 (7.14%)      1/30 (3.33%)    
General disorders     
Insomnia  1  2/28 (7.14%)  3 0/30 (0.00%)  0
Pain: Chest Wall  1  0/28 (0.00%)  0 1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders     
Muscle Cramps  1  0/28 (0.00%)  0 1/30 (3.33%)  2
Nervous system disorders     
Headache  1  1/28 (3.57%)  1 0/30 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I - Donepezil Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   28/28 (100.00%)      30/30 (100.00%)    
Gastrointestinal disorders     
Diarrhea  1  7/28 (25.00%)  11 6/30 (20.00%)  9
Nausea  1  8/28 (28.57%)  10 8/30 (26.67%)  12
General disorders     
Anorexia  1  4/28 (14.29%)  5 7/30 (23.33%)  11
Fatigue  1  20/28 (71.43%)  49 19/30 (63.33%)  49
Insomnia  1  18/28 (64.29%)  37 21/30 (70.00%)  49
Musculoskeletal and connective tissue disorders     
Muscle Cramps  1  15/28 (53.57%)  29 8/30 (26.67%)  14
Pain: joint  1  0/28 (0.00%)  0 2/30 (6.67%)  2
Nervous system disorders     
Cognitive Disturbance  1  2/28 (7.14%)  2 0/30 (0.00%)  0
Headache  1  11/28 (39.29%)  15 8/30 (26.67%)  15
Neuropathy: sensory  1  3/28 (10.71%)  5 2/30 (6.67%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Doug Case
Organization: Wake Forest School of Medicine
Phone: 336-716-1048
EMail: dcase@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01466270     History of Changes
Other Study ID Numbers: IRB00019792-1
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU 97211 ( Other Identifier: NCI )
First Submitted: November 2, 2011
First Posted: November 7, 2011
Results First Submitted: December 31, 2014
Results First Posted: January 9, 2015
Last Update Posted: August 9, 2018