Study of Aerobic Training for People Receiving Treatment for Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Female
Histological confirmation
As per standard of care imaging
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Adaptive Aerobic Training/AT Dosing
Behavioralo 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.
Standard (fixed) Aerobic Training/AT dosing
BehavioralIn 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Adaptive Aerobic Training/AT DosingExperimental treatment 1 intervention
Group B: Standard (fixed) Aerobic Training/AT dosingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiorespiratory fitness (CRF) response rate
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 (\~32 weeks) 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.
Time frame
32 weeks from baselineSponsors and contacts
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Source ClinicalTrials.gov