Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer; Breast Carcinoma

Treatments: Behavioral: Adaptive Aerobic Training/AT Dosing; Behavioral: Standard (fixed) Aerobic Training/AT dosing

Study type: Interventional

Funder types: Other

Identifiers

NCT05716893

22-364

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Adaptive Aerobic Training/AT Dosing

Experimental group

Description:

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Treatment:

Behavioral: Adaptive Aerobic Training/AT Dosing

Standard (fixed) Aerobic Training/AT dosing

Active Comparator group

Description:

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Treatment:

Behavioral: Standard (fixed) Aerobic Training/AT dosing