Breast Cancer Clinical Trial
A Study of the Body’s Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
Summary
The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.
Eligibility Criteria
Inclusion Criteria:
Patients with histologically-confirmed, HR-positive (ER and/or PR) stage 1-3 breast cancer
Completed anti-HER2 therapy, if HER2-positive
Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
At least 3 months post completion of chemotherapy, if administered
At least 3 months post radiation, if administered
Receiving adjuvant endocrine therapy with an aromatase inhibitor (anastrozole, letrozole, exemestane)
ECOG performance status of 0 to 1
Sedentary (i.e.,performing <150 minutes / week of exercise structured moderate-intensity or strenuous-intensity)
Age ≥ 18
BMI ≥ 27
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria and in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator:
Achieved 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., within10 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
Intact breast available for biopsy
Exclusion Criteria:
Presence of metastatic disease
Any concurrent malignancy requiring active treatment with the exception of selective estrogen receptor modulators and aromatase inhibitors
Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on insulin therapy
Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise or diet on study outcomes
Mental impairment leading to inability to cooperate
Any of the following contraindications to exercise:
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
Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
Nut or legume allergy
Concurrent participation in weight loss programs
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There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States More Info
Middletown New Jersey, 07748, United States More Info
Montvale New Jersey, 07645, United States More Info
Commack New York, 11725, United States More Info
Harrison New York, 10604, United States More Info
Uniondale New York, 11553, United States More Info
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