Breast Cancer Stage IV, Metastatic Breast Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALPlant-Based Diet
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.
Sponsors
Johns Hopkins University
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 1 year | Percentage of women who are randomized in the study out of the all women approached. |
| Retention | 8 weeks | Percentage of women who start the intervention who go on to complete 8-week testing |
| Compliance | 8 weeks | The percentage of daily calorie intake from on-plan food will be calculated for each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Fatigue Inventory (BFI) | 8 weeks | — |
| Symptom Inventory | 8 weeks | — |
| Serum breast cancer biomarkers | 8 weeks | CA 15-3, CEA, CA 27.29 |
| 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 | 8 weeks | Assess baseline diet compared to intervention diet |
| Weight | 8 weeks | — |
| FACT-B | 8 weeks | — |
| Inflammatory Markers | 8 weeks | CBC, CRP |
| Hormonal Levels | 8 weeks | Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3 |
| Metabolic Markers | 8 weeks | Lipids, CMP |
| Tumor Metabolic Activity | 8 weeks | PET/CT scan SUV Uptake |
| Circulating Tumor Cells | 8 weeks | — |
| cell-free DNA | 8 weeks | — |
| Blood Pressure | 8 weeks | — |
| EORTC QLQ-C30 | 8 weeks | — |
| FACT-COG | 8 weeks | — |
Countries
United States
Outcome results
None listed