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RECRUITING
NCT05716893
PHASE2

Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2023-01-30

Completion Date

2028-01-30

Last Updated

2026-03-10

Healthy Volunteers

No

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 be monitored using TeleEx.

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.

Locations (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited protocol activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited protocol activities)

Rockville Centre, New York, United States