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Trial record 4 of 1526 for:    food | cancer

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

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ClinicalTrials.gov Identifier: NCT03045289
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : December 21, 2018
Sponsor:
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
Thomas M Campbell, University of Rochester

February 1, 2017
February 7, 2017
December 21, 2018
January 5, 2018
December 31, 2019   (Final data collection date for primary outcome measure)
  • Recruitment [ Time Frame: 1 year ]
    Percentage of women who are randomized in the study out of the all women approached.
  • Retention [ Time Frame: 8 weeks ]
    Percentage of women who start the intervention who go on to complete 8-week testing
  • Compliance [ Time Frame: 8 weeks ]
    The percentage of daily calorie intake from "on-plan" food will be calculated for each participant.
  • Feasibility Percent [ Time Frame: 1 year ]
    Number of subjects consented divided by number of subjects approached
  • Compliance Percent [ Time Frame: 6 weeks ]
    Number of subjects that consume meals provided and "on-plan" supplemental foods while avoiding foods and meals not within the protocol guidelines divided by all subjects
Complete list of historical versions of study NCT03045289 on ClinicalTrials.gov Archive Site
  • FACT-B [ Time Frame: 8 weeks ]
  • EORTC QLQ-C30 [ Time Frame: 8 weeks ]
  • FACT-COG [ Time Frame: 8 weeks ]
  • Brief Fatigue Inventory (BFI) [ Time Frame: 8 weeks ]
  • Symptom Inventory [ Time Frame: 8 weeks ]
  • Serum breast cancer biomarkers [ Time Frame: 8 weeks ]
    CA 15-3, CEA, CA 27.29
  • Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT) [ Time Frame: 8 weeks ]
  • Changes in nutrient intakes based on 3 day food diaries [ Time Frame: 8 weeks ]
    Assess baseline diet compared to intervention diet
  • Weight [ Time Frame: 8 weeks ]
  • Blood Pressure [ Time Frame: 8 weeks ]
  • Inflammatory Markers [ Time Frame: 8 weeks ]
    CBC, CRP
  • Hormonal Levels [ Time Frame: 8 weeks ]
    Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3
  • Metabolic Markers [ Time Frame: 8 weeks ]
    Lipids, CMP
  • Tumor Metabolic Activity [ Time Frame: 8 weeks ]
    PET/CT scan SUV Uptake
  • Circulating Tumor Cells [ Time Frame: 8 weeks ]
  • cell-free DNA [ Time Frame: 8 weeks ]
  • Serum breast cancer biomarkers [ Time Frame: 6 weeks ]
    CA 15-3, CEA, CA 27.29
  • EORTC QLQ-C30 [ Time Frame: 6 weeks ]
  • Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT) [ Time Frame: 8 weeks ]
  • Average nutrient intakes based on 3 day food diaries [ Time Frame: 3 days ]
    Assess baseline diet compared to intervention diet
  • Weight [ Time Frame: 6 weeks ]
  • Blood Pressure [ Time Frame: 6 weeks ]
  • FACT-B [ Time Frame: 6 weeks ]
  • FACT-COG [ Time Frame: 6 weeks ]
Not Provided
Not Provided
 
A Whole-food, Plant-Based Nutrition Intervention in Women With Metastatic Breast Cancer
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
  • Metastatic Breast Cancer
  • Breast Cancer Stage IV
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.
  • Experimental: Intervention group
    Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.
    Intervention: Behavioral: Plant-Based Diet
  • No Intervention: Control Group
    Women instructed to maintain current intake and take a provided multivitamin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
60
December 31, 2019
December 31, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Only women will be enrolled due to low numbers of male breast cancer patients and inability to create subgroup analyses.
18 Years and older   (Adult, Older Adult)
No
Contact: Study Coordinator 585-341-9921 kelly-jo_koch@urmc.rochester.edu
Contact: Erin K Campbell, MD MPH erin_campbell@urmc.rochester.edu
United States
 
 
NCT03045289
RSRB00066846
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.
Thomas M Campbell, University of Rochester
University of Rochester
Johns Hopkins University
Principal Investigator: Thomas M Campbell, MD University of Rochester
University of Rochester
December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP