Clinical trial NCT04298086: A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Primary Hormone Receptor Positive Breast Cancer
Keywords: Postmenopausal Women
Overweight/Obese
Plant-Based Diet
19-486
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: McGill University
name: University of Kansas Medical Center
name: Wake Forest University
First posted: 2020-03-06
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: change in breast aromatase levels
timeFrame: 24 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neil Iyengar, MD
role: PRINCIPAL_INVESTIGATOR
References: