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

Breast Cancer Clinical Trial

— WISER-WIN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05428709
• Other study ID #: STUDY00019979
• Status: Terminated
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 29, 2023

Study information

• Verified date: July 2023
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 29, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Acute Exercise
Participants will be asked to walk or jog on a treadmill for a maximal exercise test.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Exerkine: TGF-ß	TGF-ß 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
Secondary	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
Secondary	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
Secondary	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