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

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer; Breast Cancer Stage IV
• Interventions: Behavioral: Plant-Based Diet

• Registration Number: NCT03045289
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-01
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-07
• Study Start: 2018-07-05
• Status Verified: 2022-07
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Plant-Based Diet	Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-C30	8 weeks
Hormonal Levels	8 weeks	Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3
cell-free DNA	8 weeks
Symptom Inventory	8 weeks
Inflammatory Markers	8 weeks	CBC, CRP
Blood Pressure	8 weeks
Metabolic Markers	8 weeks	Lipids, CMP
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
FACT-B	8 weeks
Brief Fatigue Inventory (BFI)	8 weeks
Tumor Metabolic Activity	8 weeks	PET/CT scan SUV Uptake
Circulating Tumor Cells	8 weeks
FACT-COG	8 weeks
Serum breast cancer biomarkers	8 weeks	CA 15-3, CEA, CA 27.29
Weight	8 weeks

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States