Clinical trial · Interventional
Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI leaving academia
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acute Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acute exercise
- description
- Participants will be asked to walk or jog on a treadmill for a maximal exercise test.
- interventionNames
- Behavioral: Acute Exercise
Primary outcomes (4)
- measure
- Changes in total hemoglobin
- timeFrame
- 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
- description
- 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).
- measure
- Changes in oxy-hemoglobin
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available