Aerobic Therapy to Improve Cardiovascular Health in Post-Menopausal Women after Treatment for Early Stage Breast Cancer
This phase II trial investigates how well aerobic therapy in different amounts over different periods of time works in improving cardiorespiratory fitness (lung, heart, blood vessel, and muscle function) in post-menopausal women with early stage breast cancer. Studying aerobic therapy via supervised walking sessions in different amounts over different periods of time may help doctors learn which types of exercise may lower the risk of cancer returning and improve cardiorespiratory fitness in women with early stage breast cancer.
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 peak oxygen volume [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 cardiopulmonary exercise testing (CPET), in the absence of high-risk electrocardiogram (ECG) findings or other inappropriate response to exercise as determined by the principal investigator (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 beats per minute [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 sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04458532.
Locations matching your search criteria
United States
Connecticut
New Britain
New York
New York
PRIMARY OBJECTIVE:
I. To compare cardiorespiratory fitness (CRF) response rates between aerobic therapy (AT) dose cohorts.
SECONDARY OBJECTIVES:
I. To compare CRF change (ml oxygen [O2] * kg^-1 * min^-1) between AT dose cohorts.
II. To compare physiological determinants of CRF between AT dose cohorts as assessed by:
IIa. Resting and peak exercise cardiac function (i.e., cardiac output);
IIb. Pulmonary function (i.e., forced expiratory volume in one second);
IIc. Arterial stiffness (i.e., carotid-femoral pulse wave velocity);
IId. Arterial-venous oxygen difference (derived from peak cardiac output and peak oxygen consumption [VO2peak]);
IIe. Hemoglobin concentration.
III. To evaluate association of each physiological determinant with CRF response.
IV. To compare patient-reported outcomes (e.g., quality of life, fatigue) between AT dose cohorts.
V. To compare the tolerability profile between AT dose cohorts.
VI. To compare the safety profile between AT dose cohorts.
EXPLORATORY OBJECTIVES:
I. To examine the magnitude and extent of detraining in primary and secondary endpoints following the cessation of supervised AT. (Arms A and D)
II. To explore change in primary and secondary endpoints among and between study arms based on AT tolerability (relative dose intensity; RDI).
III. To explore AT pharmacodynamics as evaluated by changes in physiological (e.g., body weight, blood pressure, heart rate, glucose) correlates and blood-based biomarkers.
IV. To explore feasibility of acquiring tele-guided resting cardiac function.
V. To explore baseline factors associated with CRF change at 32 weeks.
VI. To explore CRF change (ml O2.kg-1.min-1) between AT dose cohorts 1-year post-intervention.
VII. To explore patient-reported outcomes (e.g., quality of life, fatigue) between AT dose cohorts 1-year post-intervention.
VIII. To explore implementation metrics (e.g., acceptability, feasibility, adoption) at follow-up (i.e., at 32 weeks) and 1 year post-intervention.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM A: Patients complete 300 minutes of supervised walking sessions weekly for 16 weeks. Patients then receive usual care for 16 weeks. Patients also receive monthly check in calls for 32 weeks. In addition, patients undergo echocardiography (ECHO) at baseline, week 17, and at follow-up (within 2 weeks after completion of study intervention).
ARM B: Patients complete 150 minutes of supervised walking sessions weekly for 32 weeks. In addition, patients undergo ECHO at baseline, week 17, and at follow-up (within 2 weeks after completion of study intervention).
ARM C: Patients complete 300 minutes of supervised walking sessions weekly for 32 weeks. In addition, patients undergo ECHO at baseline, week 17, and at follow-up (within 2 weeks after completion of study intervention).
ARM D: Patients complete 150 minutes of supervised walking sessions weekly for 16 weeks. Patients then receive usual care for 16 weeks. Patients also receive monthly check in calls for 32 weeks. In addition, patients undergo ECHO at baseline, week 17, and at follow-up (within 2 weeks after completion of study intervention).
Patients optionally follow up at 1 year.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorJessica Scott
- Primary ID20-130
- Secondary IDsNCI-2020-05252
- ClinicalTrials.gov IDNCT04458532