Clinical trial · Interventional
Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Women In Steady Exercise Research - Neoadjuvant Exercise Trial
NCT03280836CI-TRIAL-00071988WISER-NETcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.
Conditions
Conditions (2)
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 Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Physical Activity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- We ask that participants in the control arm do not start an exercise program.
- type
- EXPERIMENTAL
- label
- Exercise
- description
- Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence. Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.
- interventionNames
- Behavioral: Exercise
Primary outcomes (3)
- measure
- Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
3.1 Inclusion Criteria * Women with a breast cancer diagnosis (Stage I-IIIC) * Sedentary (\< 75 min/wk of moderate intensity exercise over the past month) * No previous history of anthracycline based chemotherapy * Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease) * Absence of contraindications for neoadjuvant chemotherapy * Scheduled to receive neoadjuvant chemotherapy * Primary attending oncologist approval 3.2 Exclusion Criteria * Absolute contraindications for exercise stress testing * 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 noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise * mental impairment leading to inability to cooperate * decisional impairment * Non-English speaking * Women only diagnosed with ductal carcinoma in situ * Women diagnosed with stage 4 metastatic breast cancer * Pregnant women * Men * Children
References
Publications (1)
- RESULTSturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6. PMID 35216638