Study of Aerobic Training for People Receiving Chemotherapy for Breast Cancer

Conditions

• Breast Cancer
• Breast Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adaptive Aerobic Training/AT Dosing — BEHAVIORAL
  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.
• Standard (fixed) Aerobic Training/AT dosing — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jan 30, 2023

Status verified

Mar 2026

Primary completion

Jan 30, 2028

Completion

Jan 30, 2028

Study Design

Enrollment

140 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adaptive Aerobic Training/AT Dosing
  Participants with newly diagnosed primary breast cancer initiating chemotherapy.
• Active Comparator: Standard (fixed) Aerobic Training/AT dosing
  Participants with newly diagnosed primary breast cancer initiating chemotherapy.

Primary Outcome Measure

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

Central Contacts

• Jessica Scott, PhD
  646-888-8093
  [email protected]
• Anthony Yu, MD
  212-639-5154
  [email protected]

Locations (7)

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