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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-05

Study Completion Date

2022-07-01

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.

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Detailed Description

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Conditions

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Metastatic Breast Cancer Breast Cancer Stage IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.

Group Type EXPERIMENTAL

Plant-Based Diet

Intervention Type BEHAVIORAL

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.

Control Group

Women instructed to maintain current intake and take a provided multivitamin.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No