Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology (WISER-WIN)

Penn State Health

Status: Terminated

Conditions: Breast Cancer

Treatments: Behavioral: Acute Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05428709

STUDY00019979

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Acute exercise

Experimental group

Description:

Participants will be asked to walk or jog on a treadmill for a maximal exercise test.

Treatment:

Behavioral: Acute Exercise