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 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Breast Cancer Breast Cancer Stage IV||Behavioral: Plant-Based Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||July 5, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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.
- 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.
- 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 ]
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
|Contact: Erin Campbell, MD MPHfirstname.lastname@example.org|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Erin Campbell, MD MPH 585-341-9922 email@example.com|
|Principal Investigator:||Thomas M Campbell, MD||University of Rochester|