Exercise Therapy to Improve Cardiovascular Health in Post-Menopausal Women After Treatment for Early Stage Breast Cancer

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04458532
Status
Recruiting

Conditions

  • Early Stage Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Aerobic Training — OTHER
    300 min/wk for 16 weeks
  • Aerobic Training — OTHER
    150 min/wk for 32 weeks
  • Aerobic Training — OTHER
    300 min/wk for 32 weeks
  • Aerobic Training — OTHER
    150 min/wk for 16 weeks

Study Details

This study will compare the effects on cardiorespiratory fitness (CRF) of aerobic exercise in different amounts (number of minutes/session) over different periods of time (number of weeks). Aerobic exercise is physical activity of light-to-moderate intensity that uses the large muscle groups (muscles in your legs, buttocks, back, and chest) and can be performed for at least 10 minutes. The researchers will study the effects of different exercise programs on how well the study participants' bodies use oxygen, how well their heart pumps blood, how well their lungs function, and how healthy their blood vessels are.

Key Dates

Start date
Oct 8, 2020
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
152 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: (A) breast cancer after completion of chemo
    300 min/wk for 16 weeks, followed by 16 weeks of usual care.
  • Experimental: (B) breast cancer after completion of chemo
    150 min/wk for 32 weeks.
  • Experimental: (C) breast cancer after completion of chemo
    300 min/wk for 32 weeks.
  • Active Comparator: (D) breast cancer after completion of chemo
    150 min/wk for 16 weeks, followed by 16 weeks of usual care.

Primary Outcome Measure

peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate [ Time Frame: 32 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)HartfordConnecticut06102
Andrew Salner, MD
860-972-2803
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Jessica Scott, PhD
646-888-8103
Lee Jones, PhD
646-888-8103
Jessica Scott, PhD (PRINCIPAL_INVESTIGATOR)

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