Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Carcinoma; Breast Cancer
• Interventions: Behavioral: Standard (fixed) Aerobic Training/AT dosing; Behavioral: Adaptive Aerobic Training/AT Dosing

• Registration Number: NCT05716893
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

In this study, investigators will compare standard Aerobic Training/AT with adaptive Aerobic Training/AT. Standard AT will be a fixed (unchanging) amount of walking each week, while adaptive AT will adjust the level of exercise depending on participants' response to the exercise. Investigators will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-30
• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-02
• Last Update Posted: 2025-06-04
• Primary Completion: 2028-01-30
• Study Completion: 2028-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard (fixed) Aerobic Training/AT dosing	Standard (fixed) Aerobic Training/AT dosing	Participants with newly diagnosed primary breast cancer initiating chemotherapy.
Adaptive Aerobic Training/AT Dosing	Adaptive Aerobic Training/AT Dosing	Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory fitness (CRF) response rate	32 weeks from baseline	The primary endpoint will be CRF response rate as assessed by the proportion of patients with a peak oxygen consumption (VO2peak; ml O2 .kg-1.min-1 ) change from baseline (T0) to T2 (\~32 weeks) of ≥3.50 ml O2 .kg-1.min-1 . A CRF change ≥3.50 ml O2 .kg-1.min-1 will be considered a response; a change \<3.50 ml O2 .kg-1.min-1 will be considered a non-response.

Trial Locations

Locations (7)

Memorial Sloan Kettering Nassau (Limited protocol activities); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Bergen (Limited protocol activities); 🇺🇸 Montvale, New Jersey, United States