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

Pharmacodynamic Response to Exercise Treatment and Plant-Based Diet in Overweight/Obese Postmenopausal Women With Primary Hormone Receptor Positive Breast Cancer: A Phase 2 Randomized Control Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Primary Hormone Receptor Positive Breast Cancer
• Intervention / Treatment: Other: Exercise Treatment; Other: Plant-Based Diet; Other: Replication Exercise Test; Other: Physical activity; Other: Nutrition counseling

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Limited protocol activities)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Limited protocol activities)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Treatment and 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	Other: Exercise Treatment; 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.; Other: Plant-Based Diet; Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.; Other: Replication Exercise Test; Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.
Active Comparator: Physical activity and 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.	Other: Physical activity; Treadmills and low-calorie recipes will be provided to patients in the counseling arm.; Other: Nutrition counseling; Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in breast aromatase levels	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.	24 weeks post-intervention

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: McGill University; University of Kansas Medical Center; American Cancer Society, Inc.; Wake Forest University
• Investigators: Principal Investigator: Neil Iyengar, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 4, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Postmenopausal Women; Plant-Based Diet; Overweight/Obese; 19-486
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Overnutrition; Nutrition Disorders; Body Weight; Breast Neoplasms; Overweight
• Other Study ID Numbers: 19-486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No