Aerobic training for women undergoing chemotherapy for breast cancer
Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Chemotherapy for Primary Breast Cance
This study tests whether standard or adjustable aerobic training helps women undergoing chemotherapy for breast cancer improve their fitness levels.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05716893 on ClinicalTrials.gov |
What this trial studies
This study compares standard aerobic training with adaptive aerobic training for women receiving chemotherapy for breast cancer. Standard aerobic training involves a fixed amount of walking each week, while adaptive training adjusts the exercise level based on participants' responses. The goal is to evaluate how these different training approaches impact cardiorespiratory fitness (CRF) in participants. The study aims to determine which method is more effective in improving fitness during chemotherapy.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have been diagnosed with primary breast cancer and are scheduled to receive chemotherapy.
Not a fit: Patients who are already engaging in more than 90 minutes of moderate- or strenuous-intensity exercise per week may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the physical fitness and overall well-being of women undergoing chemotherapy for breast cancer.
How similar studies have performed: Other studies have shown positive outcomes with aerobic training in cancer patients, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥18 years * Female * Diagnosed with primary breast cancer as defined by one of the following: * Histological confirmation * As per standard of care imaging * Scheduled to receive neoadjuvant/adjuvant chemotherapy * Performing ≤90 minutes of moderate- and/or strenuous-intensity exercise per week, as evaluated by self-report * Willingness to comply with all study-related procedures * Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria: 1. Achieving a plateau in oxygen consumption, concurrent with an increase in power output; 2. A respiratory exchange ratio ≥ 1.10; 3. Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); 4. Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale. Exclusion Criteria: * Enrollment onto any other interventional investigational study, except interventions determined by the PI not to confound study outcomes * Receiving treatment for any other diagnosis of invasive cancer * Distant metastatic malignancy of any kind * Mental impairment leading to inability to cooperate * Any of the following contraindications to cardiopulmonary exercise testing: i. Acute myocardial infarction within 3-5 days of any planned study procedures; ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Respiratory failure; xv. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) xvi. Room air desaturation at rest ≤ 85% * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Scott, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jessica Scott, PhD
- Email: scottj1@mskcc.org
- Phone: 646-888-8093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.