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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

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Breast Cancer Stage IV Behavioral: Plant-Based Diet Not Applicable

Study Type : Interventional
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 5, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Intervention group
Subjects are provided three meals daily, attend weekly office visits, take a daily multivitamin.
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.

No Intervention: Control Group
Women instructed to maintain current intake and take a provided multivitamin.



Primary Outcome Measures :
  1. Recruitment [ Time Frame: 1 year ]
    Percentage of women who are randomized in the study out of the all women approached.

  2. Retention [ Time Frame: 8 weeks ]
    Percentage of women who start the intervention who go on to complete 8-week testing

  3. Compliance [ Time Frame: 8 weeks ]
    The percentage of daily calorie intake from "on-plan" food will be calculated for each participant.


Secondary Outcome Measures :
  1. FACT-B [ Time Frame: 8 weeks ]
  2. EORTC QLQ-C30 [ Time Frame: 8 weeks ]
  3. FACT-COG [ Time Frame: 8 weeks ]
  4. Brief Fatigue Inventory (BFI) [ Time Frame: 8 weeks ]
  5. Symptom Inventory [ Time Frame: 8 weeks ]
  6. Serum breast cancer biomarkers [ Time Frame: 8 weeks ]
    CA 15-3, CEA, CA 27.29

  7. Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT) [ Time Frame: 8 weeks ]
  8. Changes in nutrient intakes based on 3 day food diaries [ Time Frame: 8 weeks ]
    Assess baseline diet compared to intervention diet

  9. Weight [ Time Frame: 8 weeks ]
  10. Blood Pressure [ Time Frame: 8 weeks ]
  11. Inflammatory Markers [ Time Frame: 8 weeks ]
    CBC, CRP

  12. Hormonal Levels [ Time Frame: 8 weeks ]
    Estradiol, testosterone, SHBG, DHEAS, Insulin, IGF-1, IGFBP-3

  13. Metabolic Markers [ Time Frame: 8 weeks ]
    Lipids, CMP

  14. Tumor Metabolic Activity [ Time Frame: 8 weeks ]
    PET/CT scan SUV Uptake

  15. Circulating Tumor Cells [ Time Frame: 8 weeks ]
  16. cell-free DNA [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045289


Contacts
Contact: Study Coordinator 585-341-9921 kelly-jo_koch@urmc.rochester.edu
Contact: Erin K Campbell, MD MPH erin_campbell@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Study Coordinator    585-341-9921    kelly-jo_koch@urmc.rochester.edu   
Sponsors and Collaborators
University of Rochester
Johns Hopkins University
Investigators
Principal Investigator: Thomas M Campbell, MD University of Rochester

Responsible Party: Thomas M Campbell, Instructor of Clinical Family Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT03045289     History of Changes
Other Study ID Numbers: RSRB00066846
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: December 21, 2018
Last Verified: December 2018
Individual Participant Data (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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases