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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 43
- 试验地点
- 14
- 主要终点
- change in breast aromatase levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Exercise Treatment (Other)
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
干预措施: Plant-Based Diet (Other)
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
干预措施: Replication Exercise Test (Other)
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.
干预措施: Physical activity (Other)
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.
干预措施: Nutrition counseling (Other)
结局指标
主要结局
change in breast aromatase levels
时间窗: 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.
次要结局
未报告次要终点