Status:
TERMINATED
Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
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 exami...
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 ch...
Eligibility Criteria
Inclusion
- Newly diagnosed breast cancer patients
- Breast tumor is more than 2 cm (T2)
- With or without lymph node involvement (N0-3)
- With or without metastases (M0-M1)
- No initiation of neoadjuvant treatment
- Pre-surgical breast resection
Exclusion
- 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.
- Body weight \<100 lbs
- Tis, T0, T1
- Started neoadjuvant therapy
- Absolute contraindications for exercise stress testing by self-report:
- acute myocardial infarction (3-5 days)
- unstable angina
- uncontrolled arrhythmias causing symptoms or hemodynamic compromise
- syncope
- acute endocarditis
- acute myocarditis or pericarditis
- uncontrolled heart failure
- acute pulmonary embolus or pulmonary infarction
- thrombosis of lower extremities
- suspected dissecting aneurysm
- uncontrolled asthma
- pulmonary edema
- room air desaturation at rest ≤85%
- respiratory failure
- acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
- mental impairment leading to inability to cooperate
- decisional impairment
- Non-English speaking
- Pregnant women
- Children
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05428709
Start Date
February 1 2023
End Date
June 29 2023
Last Update
July 21 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033