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Trial record 4 of 1547 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

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 7, 2017
Last Update Posted Date December 21, 2018
Actual Study Start Date  ICMJE January 5, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • 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
Change History Complete list of historical versions of study NCT03045289 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • 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 ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Whole-food, Plant-Based Nutrition Intervention in Women With Metastatic Breast Cancer
Official Title  ICMJE Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Metastatic Breast Cancer
  • Breast Cancer Stage IV
Intervention  ICMJE 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.
Study Arms
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 25, 2017)
36
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2017)
60
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
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.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Contact: Study Coordinator 585-341-9921 kelly-jo_koch@urmc.rochester.edu
Contact: Erin K Campbell, MD MPH erin_campbell@urmc.rochester.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03045289
Other Study ID Numbers  ICMJE RSRB00066846
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Data will be made available for collaboration or other purposes with appropriate data use agreements in place.
Responsible Party Thomas M Campbell, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Johns Hopkins University
Investigators  ICMJE
Principal Investigator: Thomas M Campbell, MD University of Rochester
PRS Account University of Rochester
Verification Date December 2018

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