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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04298086
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : September 22, 2022
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Primary Hormone Receptor Positive Breast Cancer Other: Exercise Treatment Other: Plant-Based Diet Other: Physical activity Other: Nutrition counseling Other: Replication Exercise Test Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A single-center, phase 2 randomized control trial of structured exercise treatment and plant-based diet versus physical activity and nutrition counseling for 24 weeks.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 4, 2020
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. change in breast aromatase levels [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04298086


Contacts
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Contact: Neil Iyengar, MD 646-888-8103 iyengarn@mskcc.org
Contact: Lee Jones, PhD 646-888-8103

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Neil Iyengar, MD    646-888-8103      
Memoral Sloan Kettering Monmouth (Limited Protocol Activities) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Neil Iyengar, MD    646-888-8103      
Memorial Sloan Kettering Bergen (Limited Protocol Activities) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Neil Iyengar, MD    646-888-8103      
United States, New York
Memorial Sloan Kettering Commack (Limited Protocol Activities) Recruiting
Commack, New York, United States, 11725
Contact: Neil Iyengar, MD    646-888-8103      
Memoral Sloan Kettering Westchester (Limited Protocol Activities) Recruiting
Harrison, New York, United States, 10604
Contact: Neil Iyengar, MD    646-888-8103      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Neil Iyengar, MD    646-888-8103      
Contact: Lee Jones, PhD    646-888-8103      
Memorial Sloan Kettering Nassau (Limited Protocol Activities) Recruiting
Uniondale, New York, United States, 11553
Contact: Neil Iyengar, MD    646-888-8103      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
American Cancer Society, Inc.
Investigators
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Principal Investigator: Neil Iyengar, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04298086    
Other Study ID Numbers: 19-486
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Postmenopausal Women
Overweight/Obese
Plant-Based Diet
19-486
Additional relevant MeSH terms:
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Breast Neoplasms
Overweight
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Body Weight