Breast CancerWISER-WINNCT05428709
Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
A study testing Acute Exercise in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Acute Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 29 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
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.
Read the 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
- Being tested
- Acute Exercise
- Keywords
- acute exercise, ctDNA, exerkines, tumor perfusion, oxygen saturation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute ExerciseBehavioural
Participants will be asked to walk or jog on a treadmill for a maximal exercise test.
| Study group | Role | What they receive |
|---|---|---|
| Acute exercise | Experimental | Participants will be asked to walk or jog on a treadmill for a maximal exercise test. Receives: Behavioral: Acute Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
ctDNA level will be measured in blood and the % difference will be determined at Time 0, Time 1, Time 2, and Time 3.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Feb 2023
- Primary completion22 Jun 2023
- Study completion29 Jun 2023
Why it stopped: PI leaving academia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Sturgeon, Milton S. Hershey Medical Center
- Investigators
- Kathleen Sturgeon, PhD, MEd, MS, Principal investigator, Penn state University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428709
- Sponsor's protocol ID
- STUDY00019979
- Acronym
- WISER-WIN
- Status last verified
- Jul 2023
- First submitted
- 22 Apr 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
- ClinicalTrials.gov ID
- NCT05428709
- Acronym / sponsor ID
- WISER-WIN / STUDY00019979
- Conditions
- Breast Cancer
- Keywords
- acute exercise, ctDNA, exerkines, tumor perfusion, oxygen saturation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI leaving academia
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute exercise | Experimental | Behavioral: Acute ExerciseParticipants will be asked to walk or jog on a treadmill for a maximal exercise test. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute ExerciseParticipants will be asked to walk or jog on a treadmill for a maximal exercise test. | Behavioural | Acute exercise |
Primary outcome
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).
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.
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.
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.
5 secondary outcomes
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
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
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
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
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
Results and safety
The study was stopped early (reason given: PI leaving academia). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Sturgeon, PhD, MEd, MS principal investigator
Penn state University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Exercise in people with Breast Cancer, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI leaving academia). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.