Study of Aerobic Training (AT) for People Receiving Chemotherapy for Breast Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05716893

Collaborator

(none)

140

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, researchers 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. Researchers will see how both study approaches (standard AT and adaptive AT) affect participants' CRF.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Carcinoma	Behavioral: Adaptive Aerobic Training/AT Dosing Behavioral: Standard (fixed) Aerobic Training/AT dosing	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 30, 2023

Anticipated Primary Completion Date :

Jan 30, 2028

Anticipated Study Completion Date :

Jan 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adaptive Aerobic Training/AT Dosing Participants with newly diagnosed primary breast cancer initiating chemotherapy.	Behavioral: Adaptive 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), or 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 non-CRF responders (Δ<3.50 ml O2 .kg-1.min-1 from T0 to T2) or ~20 weeks of usual care unsupervised AT in CRF responders (Δ>3.50 ml O2 .kg-1.min-1 from T0 to T2). Supervised AT will be monitored using TeleEx, a telemedicine solution pioneered in our program.
Active Comparator: Standard (fixed) Aerobic Training/AT dosing Participants with newly diagnosed primary breast cancer initiating chemotherapy.	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), or 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 non-CRF responders (Δ<3.50 ml O2 .kg-1.min-1 from T0 to T2) or ~20 weeks of usual care unsupervised AT in CRF responders (Δ>3.50 ml O2 .kg-1.min-1 from T0 to T2). Supervised AT will be monitored using TeleEx, a telemedicine solution pioneered in our program.

Arm

Intervention/Treatment

Experimental: Adaptive Aerobic Training/AT Dosing

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Behavioral: Adaptive 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), or 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 non-CRF responders (Δ<3.50 ml O2 .kg-1.min-1 from T0 to T2) or ~20 weeks of usual care unsupervised AT in CRF responders (Δ>3.50 ml O2 .kg-1.min-1 from T0 to T2). Supervised AT will be monitored using TeleEx, a telemedicine solution pioneered in our program.

Active Comparator: Standard (fixed) Aerobic Training/AT dosing

Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Behavioral: Standard (fixed) Aerobic Training/AT dosing

Outcome Measures

Primary Outcome Measures

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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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:

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:

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;

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited protocol activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited protocol activities)	Rockville Centre	New York	United States	11553