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

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

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 Overview

• Status: Completed
• Conditions: Metastatic Breast Cancer; Breast Cancer Stage IV
• Intervention / Treatment: Behavioral: Plant-Based Diet

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Weight		8 weeks
Blood Pressure		8 weeks
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
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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2018
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: February 1, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 13, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RSRB00066846

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No