NCT04374747

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

Status unknown NA Last updated 4 November 2022

What this trial tests

NA trial testing Dietary Counseling in Breast Cancer Female in 400 participants. Status unknown.

Timeline

24 October 2019

Primary endpoint
1 April 2024

1 April 2024

Quick facts

Lead sponsor	University of Massachusetts, Amherst
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	400
Start date	24 October 2019
Primary completion	1 April 2024
Estimated completion	1 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Dietary Counseling

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →
• Inflammation — all drugs for Inflammation →
• Postpartum Weight Retention — all drugs for Postpartum Weight Retention →
• Diet, Healthy — all drugs for Diet, Healthy →

Sponsor

University of Massachusetts, Amherst

Who can join

18 and older, female only, with Breast Cancer Female or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antioxidants for the Treatment of Breast Cancer: Are We There Yet?
   Griñan-Lison C, Blaya-Cánovas JL, López-Tejada A, Ávalos-Moreno M, et al · · 2021 · cited 43× · PMID 33572626 · DOI 10.3390/antiox10020205
2. Halophilic Carotenoids and Breast Cancer: From Salt Marshes to Biomedicine.
   Giani M, Montoyo-Pujol YG, Peiró G, Martínez-Espinosa RM. · · 2021 · cited 21× · PMID 34822465 · DOI 10.3390/md19110594
3. New Moms Wellness Study: the randomized controlled trial study protocol for an intervention study to increase fruit and vegetable intake and lower breast cancer risk through weekly counseling and supplemental fruit and vegetable box delivery in breastfeeding women.
   Sturgeon SR, Sibeko L, Balasubramanian R, Arcaro KF. · · 2022 · cited 2× · PMID 36153518 · DOI 10.1186/s12905-022-01967-9
4. Subclinical mastitis during lactation: a modifiable risk factor for breast cancer?
   Schneider SS, Pentecost BT, Banas AR, Dalier A, et al · · 2025 · PMID 41404433 · DOI 10.1016/j.mehy.2025.111810