A Whole-food, Plant-Based Nutrition Intervention in Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.

Conditions
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Metastatic Breast Cancer, Breast Cancer Stage IV

Intervention / Treatment
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* Behavioral: Plant-Based Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with a confirmed diagnosis of metastatic breast cancer with a stable treatment regimen, demonstrated by no changes in primary cancer therapy 6 weeks prior to consent and no anticipated changes in primary cancer therapy in the 4 weeks following consent. Systemic therapy may consist of any conventional treatment including anti-hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have previously declined conventional cancer therapy are also eligible provided they meet all other eligibility criteria. Expected to survive for at least 6 months. Eligibility classification for enrollment into the study - T: any; N: any; M:1. Any ER/PR/HER2 status is eligible. Age > 18 years. Must be willing to adopt a strict, whole-foods, plant-based diet. Participant must be willing and able to comply with the protocol for the duration of the study including scheduled testing and weekly office visits. Able to speak and read English fluently. Exclusion Criteria: Inability to tolerate a normal diet. Current use of insulin or sulfonylureas. Active malabsorption syndrome at time of consent (ie. Crohn's disease, major bowel resection leading to permanent malabsorption). Current eating disorder. Uncontrolled diarrhea. Plant-based food allergies or intolerances. Recent consumption (in the past 6 months) of a vegan diet. GFR < 30 on 2 or more lab tests in the past 90 days. Serum potassium > 5.3 on 2 or more lab tests in the past 90 days. Major surgery within 2 months of starting study program. Psychiatric disorder that prohibits giving informed consent. Current smoking. Current high risk alcohol use (> 7 drinks per week). Current illicit substance use. Current warfarin use.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin. | Behavioral: Plant-Based Diet<br>* 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.<br>|
| No Intervention: Control Group<br>Women instructed to maintain current intake and take a provided multivitamin. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | Percentage of women who are randomized in the study out of the all women approached. | 1 year | 
| Retention | Percentage of women who start the intervention who go on to complete 8-week testing | 8 weeks | 
| Compliance | The percentage of daily calorie intake from on-plan food will be calculated for each participant. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FACT-B |  | 8 weeks | 
| EORTC QLQ-C30 |  | 8 weeks | 
| FACT-COG |  | 8 weeks | 
| Brief Fatigue Inventory (BFI) |  | 8 weeks | 
| Symptom Inventory |  | 8 weeks | 
| Serum breast cancer biomarkers | CA 15-3, CEA, CA 27.29 | 8 weeks | 
| Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT) |  | 8 weeks | 
| Changes in nutrient intakes based on 3 day food diaries | Assess baseline diet compared to intervention diet | 8 weeks | 
| Weight |  | 8 weeks | 
| Blood Pressure |  | 8 weeks | 
| Inflammatory Markers | CBC, CRP | 8 weeks | 
| Hormonal Levels | Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3 | 8 weeks | 
| Metabolic Markers | Lipids, CMP | 8 weeks | 
| Tumor Metabolic Activity | PET/CT scan SUV Uptake | 8 weeks | 
| Circulating Tumor Cells |  | 8 weeks | 
| cell-free DNA |  | 8 weeks |