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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04298086
• Other study ID #: 19-486
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 4, 2020
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Overweight
• Primary Hormone Receptor Positive Breast Cancer

Intervention

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.
• 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.
• Physical activity
Treadmills and low-calorie recipes will be provided to patients in the counseling arm.
• Nutrition counseling
Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).
• Replication Exercise Test
Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	American Cancer Society, Inc., McGill University, University of Kansas Medical Center, Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center