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Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk

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ClinicalTrials.gov Identifier: NCT04374747
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : November 4, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Massachusetts, Amherst

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 5, 2020
Last Update Posted Date November 4, 2022
Actual Study Start Date  ICMJE October 24, 2019
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • DNA methylation [ Time Frame: 20 weeks ]
    % methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk
  • Inflammatory markers in milk [ Time Frame: 20 weeks ]
    Adiponectin, CRP, IFN-y, IL1-beta, Leptin, IL-6, IL-8, TNF-alpha, b-FGF, FLT-1, PLGF, VegF-D
  • Early weight [ Time Frame: 20 weeks ]
    maternal weight
  • Early waist circumference [ Time Frame: 20 weeks ]
    maternal waist circumference
  • One-year Weight [ Time Frame: One-year ]
    maternal weight
  • One-year Waist Circumference [ Time Frame: one year ]
    maternal weight circumference
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 4, 2020)
Fruit and Vegetable Intake [ Time Frame: one year ]
servings per day
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk
Official Title  ICMJE Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight
Brief Summary Mechanistic data show that compounds in fruits and vegetables have anti-inflammatory and anti-carcinogenic properties that can reduce breast cancer risk. However, observational and interventional studies have provided mixed results, and a recent report by the American Institute for Cancer Research (AICR) concludes that the data are insufficient but suggestive that non-starchy vegetables and foods containing carotenoids reduce risk. Measurement error, relatively low levels of carotenoid-rich fruit and vegetable intake in the study populations, emphasis on diet in later adulthood, and confounding factors likely contribute to the weak associations. Therefore, the investigators will conduct a randomized diet intervention trial in young women to assess the extent to which at least 8 to 10 daily servings of deeply pigmented and nutrient dense fruits and vegetables reduces biomarkers of breast cancer risk. The intervention is focused on breastfeeding women because: 1) pregnancy and lactation are normal early life course events; 2) the risk of pregnancy-associated breast cancer (PABC) is increased for up to 10 years postpartum; 3) a dietary intervention to reverse the detrimental molecular changes associated with puberty and pregnancy is more likely to be successful in younger than in older women;4) a diet rich in fruits and vegetables is hypothesized to reduce the inflammation during lactation/weaning and lower PABC risk; 5) postpartum lactating women may be a highly motivated population; and 6) breastmilk provides access to the breast microenvironment and breast epithelial cells to non-invasively assess the diet intervention directly in the breast. Four hundred nursing mothers will be randomly assigned to either the intervention arm, in which they are asked to increase fruit and vegetable intake to at least 8 to 10 daily servings for one year, or to a control condition in which participants receive a dietary guideline for breastfeeding mothers. Women in the intervention arm will receive counseling and boxes of fruits and vegetables for the first 20 weeks, after which they will continue to receive counseling. Changes in DNA methylation and cytokine profiles in breastmilk will be evaluated. Maternal weight and body fat distribution, and infant growth will be monitored. These results will greatly expand our knowledge of how diet alters molecular pathways in a specific organ, ultimately contributing to both breast cancer etiology and prevention.
Detailed Description

Overview of home visits and activities completed by all participants

Visit 1 Introductory Visit (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 5 weeks postpartum

  • Informed Consent document administered.
  • Public Data Sharing Informed Consent document administered.
  • Three questionnaires: New Moms Health, Physical Activity, and Breastfeeding Practices
  • Maternal height, weight, and waist circumference measured.
  • Instructions provided for future collection of biospecimens.
  • Complete one 24-Hour Dietary Recall
  • Instructions provided for two additional 24-Hour Dietary Recalls.

Visit 2 Sample Collection 1 (1.5 hours) Occurs at 6 weeks postpartum

  • Provide bilateral breast milk samples and completed questionnaire.
  • Provide infant stool sample and completed questionnaire.
  • Two questionnaires: Infant Feeding, and Medication & Supplement
  • Infant length and weight measured.
  • Maternal and infant skin carotenoids measured.
  • Nutrition education provided.
  • Optional collection of maternal stool sample and completed questionnaire.

Visit 3 Sample Collection 2 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 16 weeks postpartum

  • Provide bilateral breast milk samples and completed questionnaire.
  • Provide infant stool sample and completed questionnaire.
  • Three questionnaires: Physical Activity, Infant Feeding, and Medication & Supplement
  • Infant length and weight measured.
  • Maternal weight and waist circumference measured.
  • Maternal and infant skin carotenoids measured.

Visit 4 Sample Collection 3 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 26 weeks postpartum

  • Provide bilateral breast milk samples and completed questionnaire.
  • Provide infant stool sample and completed questionnaire.
  • Three questionnaires: Physical Activity, Infant Feeding, and Medication & Supplement.
  • Infant length and weight measured.
  • Maternal weight and waist circumference measured.
  • Maternal and infant skin carotenoids measured.
  • Optional collection of maternal stool samples and completed questionnaire.

Visit 5 Sample Collection 4 (1.5 hours) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at 58 weeks postpartum

  • Provide bilateral breast milk samples and completed questionnaire.
  • Provide infant stool sample and completed questionnaire.
  • Four questionnaires: Physical Activity, Infant Feeding, Medication and Supplement, and Breast Health
  • Infant length and weight measured.
  • Maternal weight and waist circumference measured.
  • Maternal and infant skin carotenoids measured.
  • Optional collection of maternal stool samples and completed questionnaire.

Annual Follow-up Visit (Maximum of 2) (1 hour) 24-Hour Dietary Recalls completed during the week (1-2 hours) Occurs at one-year intervals after Visit 5

  • Three questionnaires: Physical Activity, Breast Health, Young Child Feeding
  • Infant height and weight measured.
  • Maternal weight and waist circumference measured.
  • Maternal and infant skin carotenoids measured.

Monthly Inquiry (1 - 2 minutes) Occurs monthly until no longer breastfeeding

• Complete the Breast Feeding Update Questionnaire online via a survey sent through REDCap, or through a phone call.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Key laboratory analyses will conducted by laboratories blinded to intervention arm.
Primary Purpose: Prevention
Condition  ICMJE
  • Breast Cancer Female
  • Inflammation
  • Postpartum Weight Retention
  • Diet, Healthy
  • Risk Reduction
Intervention  ICMJE Behavioral: Dietary Counseling
The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables .
Study Arms  ICMJE
  • Experimental: Dietary Intervention
    Intensive dietary counseling and fruit and vegetable box delivery.
    Intervention: Behavioral: Dietary Counseling
  • No Intervention: Information
    Control condition of information on healthy eating during breastfeeding
Publications *

*   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: May 4, 2020)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2024
Estimated Primary Completion Date April 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have given birth in past five weeks or are currently pregnant
  • Breastfeeding baby at entry into the study
  • Consuming five or fewer servings of fruits and vegetables daily at baseline
  • Live within 25 miles of Amherst MA

Exclusion Criteria:

  • Invasive breast cancer
  • Any cancer except non-melanoma skin cancer in past five years
  • History of Crohn's disease, celiac sprue, or other malabsorption syndrome, which may interfere with digesting or absorption of nutrients
  • A personal history of diabetes (excluding gestational diabetes)
  • Baseline BMI of <18.5
  • Dietary restrictions that prevent participant from eating 8 to 10 servings of fruits and vegetables
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kathleen Arcaro, PhD 413-577-1823 karcaro@umass.edu
Contact: Susan Sturgeon, DrPH 413-577-1364 ssturgeon@schoolph.umass.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04374747
Other Study ID Numbers  ICMJE 2019-5382
1R01CA230478-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
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  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.
Current Responsible Party University of Massachusetts, Amherst
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Massachusetts, Amherst
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kathleen Arcaro, PhD University of Massachusetts, Amherst
Principal Investigator: Lindiwe Sibeko, PhD University of Massachusetts, Amherst
Principal Investigator: Susan Sturgeon, DrPH University of Massachusetts, Amherst
PRS Account University of Massachusetts, Amherst
Verification Date April 2022

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