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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-04

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Exercise to Prevent Aromatase Inhibitor Side Effects in Breast Cancer Patients

NCT01954706

Breast Cancer Sarcopenia

TERMINATED NA

Exercise Training in Postmenopausal Patients With Breast Cancer

NCT01384838

Physical Activity

COMPLETED NA

Dietary and Exercise Interventions in Reducing Side Effects in Patients With Stage I-IIIa Breast Cancer Receiving Aromatase Inhibitors

NCT03953157

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 +13 more

COMPLETED NA

Exercise During Chemotherapy in Older Women With Stage I-III Breast Cancer

NCT05025059

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 +17 more

ACTIVE_NOT_RECRUITING NA

Supervised Aerobic Training During or After Chemotherapy for Operable Breast Cancer

NCT01943695

Breast Cancer

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Primary Hormone Receptor Positive Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Exercise Treatment

Intervention Type 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

Intervention Type OTHER

Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.

Replication Exercise Test

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Physical activity

Intervention Type OTHER

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

Nutrition counseling

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type OTHER

Physical activity

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

Intervention Type OTHER

Nutrition counseling

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

Intervention Type OTHER

Replication Exercise Test

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No