Actively Recruiting

Phase Not Applicable
Age: 21Years - 80Years
FEMALE
NCT04458532

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-25

152

Participants Needed

2

Research Sites

337 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 21-80 years
  • Female
  • Surgically removed early stage (I-III) primary breast cancer
  • Post-menopausal defined by one of the following: age 45 or older with no menses for at least 2 years; chemically or surgically induced menopause confirmed by oncologist; estradiol level of 30 pg/mL or less
  • At least one year but no more than five years since completing definitive cancer therapy (surgery plus radiation, chemotherapy, or trastuzumab)
  • Exercise intolerance with VO2peak below predicted for active age and sex-matched individuals
  • Able to complete a baseline cardiopulmonary exercise test without high-risk ECG findings or inappropriate exercise response
  • Willing to comply with all study procedures
Not Eligible

You will not qualify if you...

  • Recent acute myocardial infarction within 3-5 days
  • Unstable angina
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  • Recurrent fainting (syncope)
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Severe symptomatic aortic stenosis
  • Uncontrolled heart failure
  • Recent pulmonary embolus or infarction within 3 months
  • Thrombosis of lower limbs
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Respiratory failure
  • Acute non-cardiopulmonary disorders affecting exercise (e.g., infection, renal failure, thyrotoxicosis)
  • Any other actively treated cancer
  • History of other cancer treated within past 3 years except non-melanoma skin cancer
  • Stage IV metastatic disease
  • Low oxygen saturation at rest (85% or less)
  • Mental impairment preventing cooperation
  • Any condition making participant unsuitable according to investigator

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)

Hartford, Connecticut, United States, 06102

Actively Recruiting

2

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

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Research Team

J

Jessica Scott, PhD

CONTACT

L

Lee Jones, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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