Status:
UNKNOWN
Fruit and Vegetable Intervention in Lactating Women to Reduce Breast Cancer Risk
Lead Sponsor:
University of Massachusetts, Amherst
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer Female
Inflammation
Eligibility:
FEMALE
18+ years
Phase:
NA
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 stud...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04374747
Start Date
October 24 2019
End Date
April 1 2024
Last Update
November 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Massachusetts Amherst
Amherst, Massachusetts, United States, 01003