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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Acute Exercise

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in total hemoglobin	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).	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
Changes in oxy-hemoglobin	Oxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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
Changes in deoxy-hemoglobin	Deoxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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
Changes in oxygen saturation	Oxygen saturation will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ctDNA level	ctDNA level will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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
Exerkine: TGF-β	TGF-β will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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
Exerkine: VEGF-A	VEGF-A will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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
Exerkine: S1P	S1P will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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
Exerkine: TSP-1	TSP-1 will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.	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

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Kathleen Sturgeon, PhD, MEd, MS, Penn State University College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): June 22, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ctDNA; oxygen saturation; acute exercise; exerkines; tumor perfusion
• Other Study ID Numbers: STUDY00019979

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No