This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
32
Women will be provided with 3 meals daily, delivered to their home, for 8 weeks, along with a multivitamin, and will attend weekly office visits.
University of Rochester
Rochester, New York, United States
Recruitment
Percentage of women who are randomized in the study out of the all women approached.
Time frame: 1 year
Retention
Percentage of women who start the intervention who go on to complete 8-week testing
Time frame: 8 weeks
Compliance
The percentage of daily calorie intake from "on-plan" food will be calculated for each participant.
Time frame: 8 weeks
FACT-B
Time frame: 8 weeks
EORTC QLQ-C30
Time frame: 8 weeks
FACT-COG
Time frame: 8 weeks
Brief Fatigue Inventory (BFI)
Time frame: 8 weeks
Symptom Inventory
Time frame: 8 weeks
Serum breast cancer biomarkers
CA 15-3, CEA, CA 27.29
Time frame: 8 weeks
Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT)
Time frame: 8 weeks
Changes in nutrient intakes based on 3 day food diaries
Assess baseline diet compared to intervention diet
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Blood Pressure
Time frame: 8 weeks
Inflammatory Markers
CBC, CRP
Time frame: 8 weeks
Hormonal Levels
Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3
Time frame: 8 weeks
Metabolic Markers
Lipids, CMP
Time frame: 8 weeks
Tumor Metabolic Activity
PET/CT scan SUV Uptake
Time frame: 8 weeks
Circulating Tumor Cells
Time frame: 8 weeks
cell-free DNA
Time frame: 8 weeks