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

NCT05428709 | Terminated

• 1 other identifier: STUDY00019979
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

acute exercise; ctDNA; exerkines; tumor perfusion; oxygen saturation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Changes in ctDNA level

  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

  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

  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

  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

  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

Study Arms (1)

Acute exercise

EXPERIMENTAL

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

Behavioral: Acute Exercise

Interventions

Acute Exercise BEHAVIORAL

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

Acute exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathleen Sturgeon, PhD, MEd, MS

  Penn state University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: June 23, 2022
• Study Start: February 1, 2023
• Primary Completion: June 22, 2023
• Study Completion: June 29, 2023
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

US (1)