Trial Outcomes & Findings for Acute Exercise Cardioprotection From Doxorubicin (NCT NCT02006979)
NCT ID: NCT02006979
Last Updated: 2019-10-25
Results Overview
Assessed with 2D speckle tracking echocardiography
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle
Results posted on
2019-10-25
Participant Flow
Participant milestones
| Measure |
Exercise
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post
exercise: An acute bout of exercise performed 24 hours prior to every anthracycline infusion.
|
Usual Care
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
13
|
|
Overall Study
COMPLETED
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Exercise
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post
exercise: An acute bout of exercise performed 24 hours prior to every anthracycline infusion.
|
Usual Care
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Acute Exercise Cardioprotection From Doxorubicin
Baseline characteristics by cohort
| Measure |
Exercise
n=13 Participants
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
|
Usual Care
n=11 Participants
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 9 • n=5 Participants
|
50 years
STANDARD_DEVIATION 10 • n=7 Participants
|
50 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Body weight
|
69.7 kg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
72.2 kg
STANDARD_DEVIATION 12.7 • n=7 Participants
|
71.9 kg
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Hemoglobin
|
13.0 g/dL
STANDARD_DEVIATION 1.0 • n=5 Participants
|
12.7 g/dL
STANDARD_DEVIATION 1.1 • n=7 Participants
|
12.8 g/dL
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
6-month MVPA
|
214 average weekly minutes
n=5 Participants
|
124 average weekly minutes
n=7 Participants
|
165 average weekly minutes
n=5 Participants
|
|
LVEF
|
57 %
STANDARD_DEVIATION 4 • n=5 Participants
|
58 %
STANDARD_DEVIATION 3 • n=7 Participants
|
58 %
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Cardiac output
|
3.2 L/min
STANDARD_DEVIATION 0.6 • n=5 Participants
|
3.0 L/min
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.1 L/min
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Resting HR
|
69 beats per minute
STANDARD_DEVIATION 11 • n=5 Participants
|
69 beats per minute
STANDARD_DEVIATION 12 • n=7 Participants
|
69 beats per minute
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Systemic vascular resistance
|
1933 dynes·sec·cm-5
STANDARD_DEVIATION 445 • n=5 Participants
|
2074 dynes·sec·cm-5
STANDARD_DEVIATION 514 • n=7 Participants
|
1998 dynes·sec·cm-5
STANDARD_DEVIATION 472 • n=5 Participants
|
|
E/A ratio
|
1.20 no units
STANDARD_DEVIATION 0.37 • n=5 Participants
|
1.27 no units
STANDARD_DEVIATION 0.32 • n=7 Participants
|
1.23 no units
STANDARD_DEVIATION 0.34 • n=5 Participants
|
|
Mean arterial pressure
|
75 mmHg
STANDARD_DEVIATION 10 • n=5 Participants
|
76 mmHg
STANDARD_DEVIATION 11 • n=7 Participants
|
76 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Body mass index
|
25.0 kg/m2
STANDARD_DEVIATION 4.8 • n=5 Participants
|
26.7 kg/m2
STANDARD_DEVIATION 5.1 • n=7 Participants
|
25.8 kg/m2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycleAssessed with 2D speckle tracking echocardiography
Outcome measures
| Measure |
Exercise
n=13 Participants
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
|
Usual Care
n=11 Participants
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
|---|---|---|
|
Global Longitudinal Strain
Baseline
|
19.2 % deformation
Standard Deviation 1.9
|
-19.6 % deformation
Standard Deviation 1.9
|
|
Global Longitudinal Strain
24-48 h post first doxorubicin
|
21.4 % deformation
Standard Deviation 1.8
|
-21.5 % deformation
Standard Deviation 1.6
|
|
Global Longitudinal Strain
7-14 days post last doxorubicin
|
-18.7 % deformation
Standard Deviation 1.4
|
-20.3 % deformation
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cyclebiomarker of cardiac injury
Outcome measures
| Measure |
Exercise
n=13 Participants
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
|
Usual Care
n=11 Participants
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
|---|---|---|
|
NT-proBNP
Baseline
|
52 pg/mL
Standard Deviation 30
|
59 pg/mL
Standard Deviation 35
|
|
NT-proBNP
24-48 h post first doxorubicin
|
214 pg/mL
Standard Deviation 77
|
323 pg/mL
Standard Deviation 151
|
|
NT-proBNP
7-14 days post last doxorubicin
|
106 pg/mL
Standard Deviation 78
|
77 pg/mL
Standard Deviation 39
|
SECONDARY outcome
Timeframe: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cyclebiomarker of cardiac injury
Outcome measures
| Measure |
Exercise
n=13 Participants
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
|
Usual Care
n=11 Participants
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
|---|---|---|
|
Cardiac Troponin T
Baseline
|
1.3 pg/mL
Standard Deviation 2.1
|
1.5 pg/mL
Standard Deviation 2.3
|
|
Cardiac Troponin T
24-48 h post first doxorubicin
|
2.6 pg/mL
Standard Deviation 3.2
|
1.9 pg/mL
Standard Deviation 2.6
|
|
Cardiac Troponin T
7-14 days post last doxorubicin
|
13.6 pg/mL
Standard Deviation 11.2
|
11.6 pg/mL
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycleAssessed with 2D speckle tracking echocardiography
Outcome measures
| Measure |
Exercise
n=13 Participants
an acute bout of exercise performed ≤24 hours prior to each cycle of anthracyclines and no exercise for 48 hours post exercise
|
Usual Care
n=11 Participants
no exercise for 72 hours prior or 48 hours post each cycle of anthracyclines
|
|---|---|---|
|
LV Twist
24-48 h post first doxorubicin
|
20.3 degrees
Standard Deviation 8.5
|
22.4 degrees
Standard Deviation 7.8
|
|
LV Twist
7-14 days post last doxorubicin
|
15.7 degrees
Standard Deviation 6.5
|
15.6 degrees
Standard Deviation 6.6
|
|
LV Twist
Baseline
|
16.4 degrees
Standard Deviation 7.6
|
16.4 degrees
Standard Deviation 5.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: <1 week before the first doxorubicin, <3 days before the 2nd, 3rd, and 4th doxorubicin, 7-14 days after completion of the last doxorubicin cycleAs assessed by standardized scores of physical and psychological distress by the Rotterdam Symptom Checklist
Outcome measures
Outcome data not reported
Adverse Events
Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Amy Kirkham, Postdoctoral Research Fellow
University of Alberta
Phone: 7804926874
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place