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

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jul 2, 2020

Keywords

ClinConnect Summary

This clinical trial is looking at how different amounts of aerobic exercise can improve heart and lung health in post-menopausal women who have been treated for early stage breast cancer. Aerobic exercise includes activities like walking, cycling, or swimming that get your heart rate up and can be done for at least 10 minutes at a time. The study will compare various exercise programs to see how they affect participants’ ability to use oxygen, how well their heart pumps blood, and the overall health of their lungs and blood vessels.

To join the study, participants need to be women aged 21 to 80 who have had surgery for early stage breast cancer and are now post-menopausal. They should also be experiencing some difficulty with exercise. Participants will undergo some tests to ensure they can safely take part in the exercises. Throughout the trial, they can expect to engage in structured exercise sessions while being closely monitored. It’s important to know that this study is currently recruiting participants, and those interested should discuss their eligibility with their healthcare provider.

Gender

FEMALE

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.