Clinical trial

A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT04298086

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexFemale
Healthy volunteersNot accepted
ConditionBreast Cancer, Primary Hormone Receptor Positive Breast Cancer

Full registry 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: 1. Acute myocardial infarction within 3-5 days of any planned study procedures; 2. Unstable angina 3. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise 4. Recurrent syncope 5. Active endocarditis 6. Acute myocarditis or pericarditis 7. Symptomatic severe aortic stenosis 8. Uncontrolled heart failure 9. Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures 10. Thrombosis of lower extremities 11. Suspected dissecting aneurysm 12. Uncontrolled asthma 13. Pulmonary edema 14. Respiratory failure 15. 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

Treatments and study arms

Exercise Treatment

Other

Exercise treatment will consist of individualized walking delivered up to 7 times weekly to achieve the patient-specific goal energy expenditure. Training sessions will be performed on a treadmill at under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service.

Plant-Based Diet

Other

Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.

Physical activity

Other

Treadmills and low-calorie recipes will be provided to patients in the counseling arm.

Nutrition counseling

Other

Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).

Replication Exercise Test

Other

Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.

Primary outcomes

change in breast aromatase levels24 weeks post-intervention

Will explore the data using descriptive statistics and graphical methods, such as summarizing the aromatase levels at baseline and at 24 weeks using means and medians and plotting the data to visualize changes over time. To compare the aromatase levels at 24 weeks post-intervention between the groups, an analysis of covariance (ANCOVA) model will be used.

Study locations

7 locations were listed when this page was built. The first 40 are shown.

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)🇺🇸 Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Commack (Limited Protocol Activities)🇺🇸 Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)🇺🇸 Harrison, New York, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)🇺🇸 Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)🇺🇸 Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center🇺🇸 New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)🇺🇸 Uniondale, New York, United States