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NCT Number: NCT04298086

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Respiratory failure
  • 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

Treatment and study plan

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

  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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • McGill University
  • University of Kansas Medical Center
  • Wake Forest University

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2020
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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