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

  • STATUS
    Recruiting
  • End date
    Jul 16, 2025
  • participants needed
    152
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 7 October 2022

Summary

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.

Description

Prior to the initiation of every supervised aerobic training session, patient resting vital signs will be assessed to ensure the patient can safely proceed with the session. Vital signs, including resting heart rate and blood pressure, will be collected and monitored per ExOnc program guidelines. In addition, the planned session will not be initiated if the ExOnc staff member observes any concerns that may compromise participant safety and/or the integrity of the planned session. Vital sign monitoring guidelines for unsupervised sessions, prescribed at lower intensities, will be advised by the exercise physiologist at the time the session plan is provided to the patient. Patients will be instructed to not begin an unsupervised session if their resting heart rate or blood pressure is outside the recommended guidelines.

Details
Condition Early Stage Breast Cancer
Treatment Aerobic Training
Clinical Study IdentifierNCT04458532
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
as
An interval of at least one year, but no more than five years, following the full
Surgery plus radiation
completion of definitive therapy for malignant disease. Definitive therapy is
Surgery plus chemotherapy
defined
Surgery plus trastuzumab
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
Exercise intolerance (i.e., patients must have a VO2peak below that predicted for
Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax [HRmax = 220-Age[years])
active age and sex-matched individuals. Note: Normative values are available
up to 80 years of age)
A respiratory exchange ratio ≥ 1.10
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)
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
Room air desaturation at rest ≤ 85%
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note