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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05428709
Recruitment Status : Not yet recruiting
First Posted : June 23, 2022
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Kathleen Sturgeon, Milton S. Hershey Medical Center

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Acute Exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024


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.




Primary Outcome Measures :
  1. Changes in total hemoglobin [ Time Frame: 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 ]
    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).

  2. Changes in oxy-hemoglobin [ Time Frame: 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 ]
    Oxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

  3. Changes in deoxy-hemoglobin [ Time Frame: 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 ]
    Deoxy-hemoglobin will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

  4. Changes in oxygen saturation [ Time Frame: 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 ]
    Oxygen saturation will be quantified using photoacoustic imaging and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.


Secondary Outcome Measures :
  1. Changes in ctDNA level [ Time Frame: 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 ]
    ctDNA level will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

  2. Exerkine: TGF-β [ Time Frame: 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 ]
    TGF-β will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

  3. Exerkine: VEGF-A [ Time Frame: 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 ]
    VEGF-A will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

  4. Exerkine: S1P [ Time Frame: 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 ]
    S1P will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.

  5. Exerkine: TSP-1 [ Time Frame: 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 ]
    TSP-1 will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05428709


Contacts
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Contact: Kathleen Sturgeon, PhD, MEd, MS 717-531-0003 ext 284676 kms99@psu.edu

Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Kathleen Sturgeon, PhD, MEd, MS Penn state University College of Medicine
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Responsible Party: Kathleen Sturgeon, Assistant Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT05428709    
Other Study ID Numbers: STUDY00019979
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kathleen Sturgeon, Milton S. Hershey Medical Center:
acute exercise
ctDNA
exerkines
tumor perfusion
oxygen saturation