WISER-WIN: Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
Study Details
Study Description
Brief Summary
The primary aim is to examine changes in tumor perfusion, oxygen saturation, and tumor physiology before and following acute physical activity in breast cancer patients.
The secondary aim is to examine changes in circulating tumor DNA (ctDNA) levels before and following acute physical activity in breast cancer patients.
The tertiary aim is to explore changes in circulating exerkines (cytokines and growth factors altered by exercise) before and following acute physical activity in breast cancer patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The proposed study seeks to leverage acute exercise physiology as a tool to better understand multiple clinical and mechanistic issues in exercise oncology. An acute exercise bout causes functional changes such as increases in heart rate and stroke volume leading to increased cardiac output and increased systemic blood flow. These systemic effects also increase tumor blood flow (perfusion). Additionally, an increase in mean arterial pressure increases oxygen diffusion distance within the tumor. Further, acute exercise mobilizes NK cells, cytokine signaling, and a myriad of other molecular and cellular transducers of exercise. Our study of acute exercise physiology in breast cancer patients will address several significant knowledge gaps both clinically and mechanistically.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acute exercise Participants will be asked to walk or jog on a treadmill for a maximal exercise test. |
Behavioral: Acute Exercise
Participants will be asked to walk or jog on a treadmill for a maximal exercise test.
|
Outcome Measures
Primary Outcome Measures
- Changes in total hemoglobin [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
Total hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined 1) before cardiopulmonary exercise (CPET) (Time 0), 2) immediately after CPET (Time 1), 3) 30 min after CPET (Time 2) , and 4) 2 hours after CPET (Time 3).
- Changes in oxy-hemoglobin [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
Oxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
- Changes in deoxy-hemoglobin [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
Deoxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
- Changes in oxygen saturation [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
Oxygen saturation will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
Secondary Outcome Measures
- Changes in ctDNA level [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
ctDNA level will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
- Exerkine: TGF-β [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
TGF-β will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
- Exerkine: VEGF-A [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
VEGF-A will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
- Exerkine: S1P [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
S1P will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
- Exerkine: TSP-1 [baseline or before cardiopulmonary exercise (CPET), immediately after CPET (an average of 12 min following baseline), 30 min following CPET, and 2 hours following CPET]
TSP-1 will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly diagnosed breast cancer patients
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Breast tumor is more than 2 cm (T2)
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With or without lymph node involvement (N0-3)
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With or without metastases (M0-M1)
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No initiation of neoadjuvant treatment
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Pre-surgical breast resection
Exclusion Criteria:
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Current use of anticoagulants, including Vitamin K antagonists (e.g. Warfarin), Direct Oral Anticoagulants (DOACs) (e.g. Pradaxa, Eliquis, Xarelto, Bevyxxa, Savaysa), low molecular weight heparins (LMWH), Fragmin, Lovenox, heparin.
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Body weight <100 lbs
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Tis, T0, T1
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Started neoadjuvant therapy
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Absolute contraindications for exercise stress testing by self-report:
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acute myocardial infarction (3-5 days)
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unstable angina
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uncontrolled arrhythmias causing symptoms or hemodynamic compromise
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syncope
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acute endocarditis
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acute myocarditis or pericarditis
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uncontrolled heart failure
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acute pulmonary embolus or pulmonary infarction
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thrombosis of lower extremities
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suspected dissecting aneurysm
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uncontrolled asthma
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pulmonary edema
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room air desaturation at rest ≤85%
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respiratory failure
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acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
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mental impairment leading to inability to cooperate
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decisional impairment
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Non-English speaking
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Pregnant women
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Children
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn State Hershey Medical Center | Hershey | Pennsylvania | United States | 17033 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
Investigators
- Principal Investigator: Kathleen Sturgeon, PhD, MEd, MS, Penn state University College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STUDY00019979