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

A Randomized Trial to Minimize Non-Response to Aerobic Training in Post-Menopausal Women With Early Stage Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 80 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests aerobic exercise programs with different session lengths and numbers of weeks. It looks at how exercise affects the heart, lungs, blood vessels, and the body's use of oxygen. It is for women after menopause who finished treatment for early-stage breast cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and 21–80 years old.
  • Had stage I–III breast cancer removed by surgery.
  • Past menopause: age 45 or older with no periods for at least 2 years; menopause caused by medicines or surgery, as confirmed by the cancer doctor; or an estradiol hormone level of 30 pg/mL or less.
  • Finished cancer treatment 1–5 years ago. Treatment must have included surgery plus radiation, chemotherapy, or trastuzumab.
  • Have lower exercise fitness than expected for active people of the same age and sex, based on a test of oxygen use.
  • Can complete the starting heart and lung exercise test, meet the study's effort goals, and have no unsafe heart readings or other unsafe exercise responses.
  • Willing to follow all study procedures.

Who can't join

  • Have a condition that makes exercise testing unsafe. Examples include a recent heart attack, unstable chest pain, uncontrolled heart problems, repeated fainting, heart infection or swelling, blood clots, a suspected tear in a major artery, uncontrolled asthma, fluid in the lungs, breathing failure, or another illness that exercise could worsen.
  • Have another cancer that is being actively treated.
  • Had another cancer treated in the past 3 years, except non-melanoma skin cancer.
  • Have cancer that has spread to distant parts of the body, also called stage IV cancer.
  • Have a blood oxygen level of 85% or less while resting and breathing room air.
  • Have problems with thinking or understanding that prevent taking part.
  • Have another condition or illness that the study doctor believes makes the study unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Aged 21-80 years * Female * Surgically resected early stage (I-III) primary breast cancer * Post-menopausal, defined as one of the following: * Age ≥ 45 with no menses for at least 2 years * Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist * Estradiol level of ≤30 pg/mL * An interval of at least one year, but no more than five years, following the full completion of definitive therapy for malignant disease. Definitive therapy is defined as: * Surgery plus radiation * Surgery plus chemotherapy * Surgery plus trastuzumab * Exercise intolerance (i.e., patients must have a VO2peak below the predicted for active age and sex-matched individuals. (+/- the technical error of 1.32 mL/kg/min)\]. Note: Normative values are available up to 80 years of age) * Able to complete an acceptable baseline CPET, in the absence of high-risk ECG findings or other inappropriate response to exercise as determined by the PI, as defined by any of the following criteria: * Achieving a plateau in oxygen consumption, concurrent with an increase in power output; * A respiratory exchange ratio ≥ 1.10; * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]); * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale * Willingness to comply with all study-related procedures. Exclusion Criteria: * Any of the following absolute contraindications to cardiopulmonary exercise testing: * Acute myocardial infarction within 3-5 days of any planned study procedures * Unstable angina * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise * Recurrent syncope * Active endocarditis * Acute myocarditis or pericarditis * Symptomatic severe aortic stenosis * Uncontrolled heart failure * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures * Thrombosis of lower extremities * Suspected dissecting aneurysm * Uncontrolled asthma * Pulmonary edema * Respiratory failure * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis) * Presence of any other concurrent, actively treated malignancy * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer) * Presence of distant metastatic disease (i.e., stage IV) * Room air desaturation at rest ≤ 85% * Mental impairment leading to inability to cooperate. * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.

Study sites (2)

CT

NY