Trial Outcomes & Findings for Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction (NCT NCT01466270)
NCT ID: NCT01466270
Last Updated: 2021-10-20
Results Overview
Retention is the percentage of participants who stay in the study for 24 weeks.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
62 participants
Primary outcome timeframe
24 Weeks
Results posted on
2021-10-20
Participant Flow
Patients were accrued between 7/12 and 1/13 from CCOP sites across the nation.
No wash-out or run-in period. All enrolled patients were randomized.
Participant milestones
| Measure |
Arm I - Donepezil
Patients receive donepezil hydrochloride PO QD.
|
Arm II - Placebo
Patients receive placebo PO QD.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
12
|
6
|
Reasons for withdrawal
| Measure |
Arm I - Donepezil
Patients receive donepezil hydrochloride PO QD.
|
Arm II - Placebo
Patients receive placebo PO QD.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Progression
|
1
|
0
|
|
Overall Study
Toxicity
|
4
|
1
|
|
Overall Study
Multiple
|
1
|
1
|
Baseline Characteristics
Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
Baseline characteristics by cohort
| Measure |
Arm I - Donepezil
n=31 Participants
Patients receive donepezil hydrochloride PO QD.
|
Arm II - Placebo
n=31 Participants
Patients receive placebo PO QD.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
56 years
n=5 Participants
|
56 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 WeeksPopulation: All randomized patients
Retention is the percentage of participants who stay in the study for 24 weeks.
Outcome measures
| Measure |
Arm I
n=31 Participants
Patients receive donepezil hydrochloride PO QD.
donepezil hydrochloride: Given PO
|
Arm II
n=31 Participants
Patients receive placebo PO QD.
Placebo: Given PO
|
|---|---|---|
|
Retention
|
71.0 percentage of participants
Standard Error 8.3
|
80.7 percentage of participants
Standard Error 7.2
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: 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.
Compliance is the percentage of pills taken while on study (based on returned diaries)
Outcome measures
| Measure |
Arm I
n=26 Participants
Patients receive donepezil hydrochloride PO QD.
donepezil hydrochloride: Given PO
|
Arm II
n=27 Participants
Patients receive placebo PO QD.
Placebo: Given PO
|
|---|---|---|
|
Compliance
|
98.0 percentage of pills
Interval 89.6 to 100.0
|
98.0 percentage of pills
Interval 89.6 to 100.0
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All randomized participants except two who did not provide any data.
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.
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive donepezil hydrochloride PO QD.
donepezil hydrochloride: Given PO
|
Arm II
n=30 Participants
Patients receive placebo PO QD.
Placebo: Given PO
|
|---|---|---|
|
HVLT-IR
|
25.58 number of words recalled
Standard Error 1.36
|
22.94 number of words recalled
Standard Error 1.24
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: All randomized participants except two who did not provide any data.
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.
Outcome measures
| Measure |
Arm I
n=30 Participants
Patients receive donepezil hydrochloride PO QD.
donepezil hydrochloride: Given PO
|
Arm II
n=30 Participants
Patients receive placebo PO QD.
Placebo: Given PO
|
|---|---|---|
|
Fatigue
|
35.89 units on a scale
Standard Error 2.20
|
35.51 units on a scale
Standard Error 2.02
|
Adverse Events
Arm I - Donepezil
Serious events: 2 serious events
Other events: 28 other events
Deaths: 0 deaths
Arm II - Placebo
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I - Donepezil
n=28 participants at risk
Patients receive donepezil hydrochloride PO QD.
|
Arm II - Placebo
n=30 participants at risk
Patients receive placebo PO QD.
|
|---|---|---|
|
General disorders
Insomnia
|
7.1%
2/28 • Number of events 3 • 40 weeks (one month following the end of the study)
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.
|
0.00%
0/30 • 40 weeks (one month following the end of the study)
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.
|
|
Nervous system disorders
Headache
|
3.6%
1/28 • Number of events 1 • 40 weeks (one month following the end of the study)
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.
|
0.00%
0/30 • 40 weeks (one month following the end of the study)
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
0.00%
0/28 • 40 weeks (one month following the end of the study)
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.
|
3.3%
1/30 • Number of events 2 • 40 weeks (one month following the end of the study)
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.
|
|
General disorders
Pain: Chest Wall
|
0.00%
0/28 • 40 weeks (one month following the end of the study)
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.
|
3.3%
1/30 • Number of events 1 • 40 weeks (one month following the end of the study)
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.
|
Other adverse events
| Measure |
Arm I - Donepezil
n=28 participants at risk
Patients receive donepezil hydrochloride PO QD.
|
Arm II - Placebo
n=30 participants at risk
Patients receive placebo PO QD.
|
|---|---|---|
|
General disorders
Anorexia
|
14.3%
4/28 • Number of events 5 • 40 weeks (one month following the end of the study)
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.
|
23.3%
7/30 • Number of events 11 • 40 weeks (one month following the end of the study)
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.
|
|
Nervous system disorders
Cognitive Disturbance
|
7.1%
2/28 • Number of events 2 • 40 weeks (one month following the end of the study)
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.
|
0.00%
0/30 • 40 weeks (one month following the end of the study)
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.
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
7/28 • Number of events 11 • 40 weeks (one month following the end of the study)
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.
|
20.0%
6/30 • Number of events 9 • 40 weeks (one month following the end of the study)
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.
|
|
General disorders
Fatigue
|
71.4%
20/28 • Number of events 49 • 40 weeks (one month following the end of the study)
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.
|
63.3%
19/30 • Number of events 49 • 40 weeks (one month following the end of the study)
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.
|
|
Nervous system disorders
Headache
|
39.3%
11/28 • Number of events 15 • 40 weeks (one month following the end of the study)
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.
|
26.7%
8/30 • Number of events 15 • 40 weeks (one month following the end of the study)
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.
|
|
General disorders
Insomnia
|
64.3%
18/28 • Number of events 37 • 40 weeks (one month following the end of the study)
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.
|
70.0%
21/30 • Number of events 49 • 40 weeks (one month following the end of the study)
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramps
|
53.6%
15/28 • Number of events 29 • 40 weeks (one month following the end of the study)
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.
|
26.7%
8/30 • Number of events 14 • 40 weeks (one month following the end of the study)
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.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
8/28 • Number of events 10 • 40 weeks (one month following the end of the study)
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.
|
26.7%
8/30 • Number of events 12 • 40 weeks (one month following the end of the study)
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.
|
|
Nervous system disorders
Neuropathy: sensory
|
10.7%
3/28 • Number of events 5 • 40 weeks (one month following the end of the study)
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.
|
6.7%
2/30 • Number of events 3 • 40 weeks (one month following the end of the study)
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.
|
|
Musculoskeletal and connective tissue disorders
Pain: joint
|
0.00%
0/28 • 40 weeks (one month following the end of the study)
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.
|
6.7%
2/30 • Number of events 2 • 40 weeks (one month following the end of the study)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place