Clinical trial · Interventional
Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
Optimal Timing Trial: Randomized Trial of Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer
- 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 purpose of this study is to compare the effects of aerobic exercise training during and after chemotherapy for women who have recently been diagnosed with early-stage breast cancer. The participant will be instructed to self-report the session information to ExOnc staff at or before their next scheduled visit. If the participant's next scheduled visit is greater than 72 hours following an unsupervised session, ExOnc staff may reach out to the participant to retrieve the session information. Unsupervised session details will be source documented by ExOnc staff.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Training | Behavioral | — | UNRESOLVED |
| Educational Information | Behavioral | — | UNRESOLVED |
| Supervised Home Based Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Aerobic Training During Chemotherapy
- description
- The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training an intensity of at 55% to 100% of the individually determined exercise capacity VO2peak), concurrent with chemotherapy. VO2peak will be determined by the CPET performed at baseline. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
- interventionNames
- Behavioral: Aerobic Training
- type
- EXPERIMENTAL
- label
- Aerobic Training After Chemotherapy
- description
- The ultimate goal is for participants to complete approximately 3 exercise sessions week of non-linear aerobic training at an intensity 55% to 100% of the individually determined exercise capacity (VO2peak), after the completion of chemotherapy. VO2peak will be determined by the CPET performed at midpoint, or pre-surgery for neoadjuvant patients. For patients receiving adjuvant therapy, (except those who have additional surgery after chemotherapy), the aerobic training intervention must begin within 2 weeks of the patient's midpoint CPET. For patients receiving neoadjuvant or adjuvant therapy and have additional surgery after chemotherapy, the aerobic training intervention will begin within approximately 6 weeks of surgery, per the discretion of the treating physician. The weekly exercise will be achieved via 3 individual aerobic training sessions ranging from approximately 20-45 min/session. All sessions are required to be supervised unless otherwise specified by EP discretion.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Aged 21-80 years * Female * MSK histologically confirmed early-stage operable breast cancer * Scheduled to receive chemotherapy in the neoadjuvant or adjuvant setting * ECOG status of 0 or 1 * Performing less than 150 minutes of structured moderate-intensity or strenuous intensity exercise per week * If a female of child-bearing potential, must not be pregnant or planning to become pregnant during the study. a. Women \< 50 years old must have a negative pregnancy test (urine HCG or serum βHCG) within 2 weeks of beginning chemotherapy. * Able to complete an acceptable baseline cardiopulmonary exercise test (CPET), in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator. * Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: * Achieving a plateau in oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.10; * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. * Willingness to be randomized to one of the study arms Exclusion Criteria: * Presence of any other concurrent, actively treated malignancy * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer) * Presence of metastatic disease * Any of the following contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction within 3-5 days of any planned study procedures) * Unstable angina * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; * Thrombosis of lower extremities * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) or * Room air desaturation at rest ≤ 85% * Mental impairment leading to inability to cooperate. * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial
References
Publications (2)
- DERIVEDIyengar NM, Scott JM, Lee J, Lavery JA, Foug KL, Lee CP, Michalski MG, Chun SS, Harrison J, Moskowitz CS, Jones LW. Effects of exercise therapy on chemotherapy delivery and response in primary breast cancer: A secondary analysis of a randomized trial. Cancer. 2025 Jan 1;131(1):e35575. doi: 10.1002/cncr.35575. Epub 2024 Sep 22. PMID 39306704
- DERIVEDScott JM, Lee J, Michalski MG, Batch K, Simpson AL, Peoples J, Lee CP, Harrison JN, Yu AF, Sasso JP, Dang C, Moskowitz CS, Jones LW, Eves ND. Mechanisms of Exercise Intolerance Across the Breast Cancer Continuum: A Pooled Analysis of Individual Patient Data. Med Sci Sports Exerc. 2024 Apr 1;56(4):590-599. doi: 10.1249/MSS.0000000000003348. Epub 2023 Nov 27. PMID 38485730