Status:
ACTIVE_NOT_RECRUITING
A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
American Cancer Society, Inc.
McGill University
Conditions:
Breast Cancer
Primary Hormone Receptor Positive Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04298086
Start Date
March 4 2020
End Date
March 1 2026
Last Update
July 11 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, United States, 11725