Study of Aerobic Training for People Receiving Treatment for Breast Cancer

Official title

Phase 2 Trial of Adaptive Versus Standard Dosing of Aerobic Training in Patients Receiving Treatment for Primary Breast Cancer

Overview

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.

Interventions

• Behavioral Adaptive Aerobic Training/AT Dosing
  o In Phase A (\~32 weeks), AT will consist of supervised walking delivered up to 7 days per week using an adaptive dosing schedule that starts at 90 min/wk and is escalated 30 min/wk every 2 weeks to a maximal dose of 300 mins/wk. In Phase B (\~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ\<3.50 ml O2 .kg-1.min-1 from baseline to \~32 weeks, or unsupervised AT in patients with a CRF Δ\>3.50 ml O2 .kg-1.min-1 from baseline to \~32 weeks. Supervised AT will b
• Behavioral Standard (fixed) Aerobic Training/AT dosing
  In Phase A (\~32 weeks), AT will consist of supervised walking delivered up to 7 days per week to achieve a cumulative total duration of: 90 min/wk (standard fixed dosing). In Phase B (\~20 weeks), AT will consist of supervised adaptive AT dosing in patients with a CRF Δ\<3.50 ml O2 .kg-1.min-1 from baseline to \~32 weeks, or unsupervised AT in patients with a CRF Δ\>3.50 ml O2 .kg-1.min-1 from baseline to \~32 weeks. Supervised AT will be monitored using TeleEx.

Primary outcome measures

• Cardiorespiratory fitness (CRF) response rate [Time frame: 32 weeks from baseline]

Eligibility 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 systemic and/or locoregional therapy
• 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:

• 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
• Memorial Sloan Kettering Bergen (Limited protocol activities) — Montvale
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
• Memorial Sloan Kettering Nassau (Limited protocol activities) — Rockville Centre

Identifiers

NCT: NCT05716893 · 22-364

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗