RecruitingPhase 2NCT05716893

Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

140 participants

Start Date

Jan 30, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Carcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured aerobic exercise program (such as supervised cycling or walking) during chemotherapy can help women with breast cancer maintain their fitness and reduce fatigue and other side effects of treatment. **You may be eligible if...** - You are a woman aged 18 or older with a new diagnosis of breast cancer - You are scheduled to receive chemotherapy before or after surgery (neoadjuvant or adjuvant) - You currently exercise less than 90 minutes per week at moderate or higher intensity - You are able to complete a supervised exercise test (cardiopulmonary exercise test) safely **You may NOT be eligible if...** - Your breast cancer has spread to distant parts of the body - You are currently being treated for another cancer - You have serious heart conditions that make exercise unsafe (e.g., recent heart attack, uncontrolled arrhythmia, severe aortic stenosis, heart failure) - You have significant mental impairment preventing participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAdaptive 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.

BEHAVIORALStandard (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.