Breast Cancer Clinical Trial
Official title:
The Effects of Exercise Before Doxorubicin Chemotherapy on Cardiac Function
Verified date | October 2019 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In rodents, a single bout of exercise prior to injection of a chemotherapy agent used to treat breast cancer prevents or attenuates a number of markers of cardiac injury. This study will investigate whether this finding translates to human breast cancer patients. Participants scheduled to receive chemotherapy for breast cancer will be randomized to exercise or no exercise 24 hours prior to every chemotherapy treatment. The effect on cardiac function will be compared between groups noninvasively by echocardiography and electrocardiography and a venous blood draw at baseline before chemotherapy, after the first treatment and at the end of chemotherapy.
Status | Completed |
Enrollment | 27 |
Est. completion date | May 25, 2016 |
Est. primary completion date | May 25, 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - newly diagnosed with stage I-IIIA breast cancer - scheduled to receive neoadjuvant or adjuvant doxorubicin chemotherapy in cycles of 2-3 weeks long - receive their oncologist's approval to exercise - be able to complete first time point of data collection prior to first chemotherapy cycle - be able to understand and provide written informed consent in English Exclusion Criteria: - concurrent participation in a structured exercise program or study - have orthopedic limitations to exercise - pre-existing cardiovascular disease - uncontrolled hypertension (blood pressure = 140/90 mmHg) - uncontrolled diabetes - respiratory disease - current smoking status |
Country | Name | City | State |
---|---|---|---|
Canada | University of British Columbia Breast Cancer Research Exercise Gym | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | British Columbia Cancer Agency |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient-reported Symptoms | As assessed by standardized scores of physical and psychological distress by the Rotterdam Symptom Checklist | <1 week before the first doxorubicin, <3 days before the 2nd, 3rd, and 4th doxorubicin, 7-14 days after completion of the last doxorubicin cycle | |
Primary | Global Longitudinal Strain | Assessed with 2D speckle tracking echocardiography | 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle | |
Secondary | NT-proBNP | biomarker of cardiac injury | 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle | |
Secondary | Cardiac Troponin T | biomarker of cardiac injury | 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle | |
Secondary | LV Twist | Assessed with 2D speckle tracking echocardiography | 24-48 hours after first doxorubicin and 7-14 days after completion of last doxorubicin cycle |
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