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

Metastatic Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045289
• Other study ID #: RSRB00066846
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: July 2022
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Stage IV
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Percentage of women who are randomized in the study out of the all women approached.	1 year
Primary	Retention	Percentage of women who start the intervention who go on to complete 8-week testing	8 weeks
Primary	Compliance	The percentage of daily calorie intake from "on-plan" food will be calculated for each participant.	8 weeks
Secondary	FACT-B		8 weeks
Secondary	EORTC QLQ-C30		8 weeks
Secondary	FACT-COG		8 weeks
Secondary	Brief Fatigue Inventory (BFI)		8 weeks
Secondary	Symptom Inventory		8 weeks
Secondary	Serum breast cancer biomarkers	CA 15-3, CEA, CA 27.29	8 weeks
Secondary	Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT)		8 weeks
Secondary	Changes in nutrient intakes based on 3 day food diaries	Assess baseline diet compared to intervention diet	8 weeks
Secondary	Weight		8 weeks
Secondary	Blood Pressure		8 weeks
Secondary	Inflammatory Markers	CBC, CRP	8 weeks
Secondary	Hormonal Levels	Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3	8 weeks
Secondary	Metabolic Markers	Lipids, CMP	8 weeks
Secondary	Tumor Metabolic Activity	PET/CT scan SUV Uptake	8 weeks
Secondary	Circulating Tumor Cells		8 weeks
Secondary	cell-free DNA		8 weeks