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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-80
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 21-80 years

Female

Surgically resected early stage (I-III) primary breast cancer

Age ≥ 45 with no menses for at least 2 years

Disqualifiers

Acute myocardial infarction within 3-5 days of any planned study procedures

Unstable angina

Uncontrolled arrhythmia causing symptoms or hemodynamic compromise

Recurrent syncope

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic Training

    Other intervention

    300 min/wk for 16 weeks

  • Aerobic Training

    Other intervention

    150 min/wk for 32 weeks

  • Aerobic Training

    Other intervention

    300 min/wk for 32 weeks

  • Aerobic Training

    Other intervention

    150 min/wk for 16 weeks

Treatment groups

152 Participants
are divided into 4 treatment groups
Group A: (A) breast cancer after completion of chemoExperimental treatment 1 intervention
Group B: (B) breast cancer after completion of chemoExperimental treatment 1 intervention
Group C: (C) breast cancer after completion of chemoExperimental treatment 1 intervention
Group D: (D) breast cancer after completion of chemoActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

peak oxygen consumption (VO2peak; ml O2.kg-1.min) response rate

A CRF change ≥1.32 ml O2.kg-1.min-1 will be considered a response; a change \<1.32 ml O2.kg-1.min-1 will be considered a non-response.

Time frame
32 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator