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

Phase 2

Active, not recruiting

• Conditions: Breast Cancer; Primary Hormone Receptor Positive Breast Cancer
• Interventions: Other: Exercise Treatment; Other: Physical activity; Other: Nutrition counseling; Other: Plant-Based Diet; Other: Replication Exercise Test

• Registration Number: NCT04298086
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-03-04
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 43

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Treatment and Plant-Based Diet	Exercise Treatment	Will consist of structured exercise treatment plus a calorie-restricted plant-based diet. 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 under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service. Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion
Physical activity and nutrition counseling	Nutrition counseling	Patients will receive a home-based, general physical activity program and nutrition counseling. Specifically, all patients assigned to the counseling arm will receive a study kit which includes an activity tracker, heart rate monitor, scale, and tablet. Treadmills may also be provided to patients in the counseling arm if they do not already have access to one.
Exercise Treatment and Plant-Based Diet	Plant-Based Diet	Will consist of structured exercise treatment plus a calorie-restricted plant-based diet. 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 under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service. Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion
Exercise Treatment and Plant-Based Diet	Replication Exercise Test	Will consist of structured exercise treatment plus a calorie-restricted plant-based diet. 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 under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service. Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion
Physical activity and nutrition counseling	Physical activity	Patients will receive a home-based, general physical activity program and nutrition counseling. Specifically, all patients assigned to the counseling arm will receive a study kit which includes an activity tracker, heart rate monitor, scale, and tablet. Treadmills may also be provided to patients in the counseling arm if they do not already have access to one.

Primary Outcome Measures

Name	Time	Method
change in breast aromatase levels	24 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.

Trial Locations

Locations (7)

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States