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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:January 5, 2018
End Date:December 31, 2019
Contact:Study Coordinator
Email:kelly-jo_koch@urmc.rochester.edu
Phone:585-341-9921

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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.


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.
We found this trial at
1
site
60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Phone: 585-341-9921
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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