Clinical trial NCT03045289: A Whole-food, Plant-Based Nutrition Intervention in Women With Metastatic Breast Cancer
Official title: Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Breast Cancer Stage IV
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2017-02-07
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment
timeFrame: 1 year
measure: Retention
timeFrame: 8 weeks
measure: Compliance
timeFrame: 8 weeks
Secondary outcomes:
measure: FACT-B
timeFrame: 8 weeks
measure: EORTC QLQ-C30
timeFrame: 8 weeks
measure: FACT-COG
timeFrame: 8 weeks
measure: Brief Fatigue Inventory (BFI)
timeFrame: 8 weeks
measure: Symptom Inventory
timeFrame: 8 weeks
measure: Serum breast cancer biomarkers
timeFrame: 8 weeks
measure: Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT)
timeFrame: 8 weeks
measure: Changes in nutrient intakes based on 3 day food diaries
timeFrame: 8 weeks
measure: Weight
timeFrame: 8 weeks
measure: Blood Pressure
timeFrame: 8 weeks
measure: Inflammatory Markers
timeFrame: 8 weeks
measure: Hormonal Levels
timeFrame: 8 weeks
measure: Metabolic Markers
timeFrame: 8 weeks
measure: Tumor Metabolic Activity
timeFrame: 8 weeks
measure: Circulating Tumor Cells
timeFrame: 8 weeks
measure: cell-free DNA
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Thomas M Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: