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

NCT04298086 | Active Not Recruiting Phase 2

• 1 other identifier: 19-486
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer; Primary Hormone Receptor Positive Breast Cancer

Keywords

Postmenopausal Women; Overweight/Obese; Plant-Based Diet; 19-486

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Exercise Treatment and Plant-Based Diet

EXPERIMENTAL

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; Other: Plant-Based Diet; Other: Replication Exercise Test

Physical activity and nutrition counseling

ACTIVE COMPARATOR

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; Other: Nutrition counseling

Interventions

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.

Exercise Treatment and Plant-Based Diet

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.

Exercise Treatment and Plant-Based Diet

Physical activity OTHER

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

Physical activity and nutrition counseling

Nutrition counseling OTHER

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

Physical activity and nutrition counseling

Replication Exercise Test OTHER

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

Exercise Treatment and Plant-Based Diet

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• American Cancer Society, Inc.: collaborator
• McGill University: collaborator
• University of Kansas Medical Center: collaborator
• Wake Forest University: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Overweight; Obesity

Interventions

Diet, Plant-Based; Exercise

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jessica Scott, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: March 4, 2020
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (7)