RECRUITING

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

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Conditions

Early Stage Breast CancerExercise TherapyAerobic TrainingPost-Menopausal Women20-130

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-10-08
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04458532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 21-80 years
  2. * Female
  3. * Surgically resected early stage (I-III) primary breast cancer
  4. * Post-menopausal, defined as one of the following:
  5. * Age ≥ 45 with no menses for at least 2 years
  6. * Chemically and/or surgically induced menopause through ovarian suppression, as determined by the primary oncologist
  7. * Estradiol level of ≤30 pg/mL
  8. * 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:
  9. * Surgery plus radiation
  10. * Surgery plus chemotherapy
  11. * Surgery plus trastuzumab
  12. * 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)\].
  13. * 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:
  14. * Achieving a plateau in oxygen consumption, concurrent with an increase in power output;
  15. * A respiratory exchange ratio ≥ 1.10;
  16. * Attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted HRmax \[HRmax = 220-Age\[years\]);
  17. * Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale
  18. * Willingness to comply with all study-related procedures.
  1. * Any of the following absolute contraindications to cardiopulmonary exercise testing:
  2. * Acute myocardial infarction within 3-5 days of any planned study procedures
  3. * Unstable angina
  4. * Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  5. * Recurrent syncope
  6. * Active endocarditis
  7. * Acute myocarditis or pericarditis
  8. * Symptomatic severe aortic stenosis
  9. * Uncontrolled heart failure
  10. * Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
  11. * Thrombosis of lower extremities
  12. * Suspected dissecting aneurysm
  13. * Uncontrolled asthma
  14. * Pulmonary edema
  15. * Respiratory failure
  16. * Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g., infection, renal failure, thyrotoxicosis)
  17. * Presence of any other concurrent, actively treated malignancy
  18. * History of any other malignancy treated within the past 3 years (other than non-melanoma skin cancer)
  19. * Presence of distant metastatic disease (i.e., stage IV)
  20. * Room air desaturation at rest ≤ 85%
  21. * Mental impairment leading to inability to cooperate.
  22. * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the participant a poor candidate for the trial.

Contacts and Locations

Study Contact

Jessica Scott, PhD
CONTACT
646-888-8103
scottj1@mskcc.org
Lee Jones, PhD
CONTACT
646-888-8103

Principal Investigator

Jessica Scott, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Hartford Healthcare Cancer Institute @ Hartford Hospital (Data Collection Only)
Hartford, Connecticut, 06102
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Jessica Scott, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-08
Study Completion Date2025-07

Study Record Updates

Study Start Date2020-10-08
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • Exercise Therapy
  • Aerobic Training
  • Post-Menopausal Women
  • 20-130

Additional Relevant MeSH Terms

  • Early Stage Breast Cancer