Phase 1
N=27
Acute Exercise Cardioprotection From Doxorubicin
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02006979 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Global Longitudinal Strain — 19.2; -19.6; 21.4; -21.5 % deformation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of British Columbia
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Global Longitudinal Strain |
19.2; -19.6; 21.4; -21.5; -18.7; -20.3 | — |
| SECONDARY NT-proBNP |
52; 59; 214; 323; 106; 77 | — |
| SECONDARY Cardiac Troponin T |
1.3; 1.5; 2.6; 1.9; 13.6; 11.6 | — |
| SECONDARY LV Twist |
16.4; 16.4; 20.3; 22.4; 15.7; 15.6 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02006979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.