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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
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Massachusetts, Amherst

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Inflammation Postpartum Weight Retention Diet, Healthy Risk Reduction Behavioral: Dietary Counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Official Title: Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk: Effects on Breast Cell DNA Methylation, Breast Inflammation,and Weight
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Dietary Intervention
Intensive dietary counseling and fruit and vegetable box delivery.
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 .

No Intervention: Information
Control condition of information on healthy eating during breastfeeding

Primary Outcome Measures :
  1. DNA methylation [ Time Frame: 20 weeks ]
    % methylation in 300,000 CpG sites in DNA from sloughed breast epithelial cells from milk

  2. 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

  3. Early weight [ Time Frame: 20 weeks ]
    maternal weight

  4. Early waist circumference [ Time Frame: 20 weeks ]
    maternal waist circumference

  5. One-year Weight [ Time Frame: One-year ]
    maternal weight

  6. One-year Waist Circumference [ Time Frame: one year ]
    maternal weight circumference

Other Outcome Measures:
  1. Fruit and Vegetable Intake [ Time Frame: one year ]
    servings per day

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
Accepts Healthy Volunteers:   Yes

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

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): NCT04374747

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Contact: Kathleen Arcaro, PhD 413-577-1823 karcaro@umass.edu
Contact: Susan Sturgeon, DrPH 413-577-1364 ssturgeon@schoolph.umass.edu

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United States, Massachusetts
University of Massachusetts Amherst Recruiting
Amherst, Massachusetts, United States, 01003
Contact: Kathleen Arcaro, PhD         
Sponsors and Collaborators
University of Massachusetts, Amherst
National Cancer Institute (NCI)
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Massachusetts, Amherst
ClinicalTrials.gov Identifier: NCT04374747    
Other Study ID Numbers: 2019-5382
1R01CA230478-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Gestational Weight Gain
Neoplasms by Site
Breast Diseases
Skin Diseases
Pathologic Processes
Weight Gain
Body Weight Changes
Body Weight