Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology

NCT ID: NCT05428709

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-06-29

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Acute exercise

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

Group Type: EXPERIMENTAL

Acute Exercise

Intervention Type: BEHAVIORAL

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

Interventions

Acute Exercise

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Sturgeon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Sturgeon, PhD, MEd, MS

Role: PRINCIPAL_INVESTIGATOR

Penn state University College of Medicine

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00019979

Identifier Type: -

Identifier Source: org_study_id