NCT05178498

Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Longitudinal Study Evaluating the Impact of Dietary Inflammatory Potential on Breast Cancer Risk in a Cohort of Women Followed in the Breast Cancer Prevention Clinic at the Ohio State University Comprehensive Cancer Center- James Cancer Hospital and Solove Research Institute

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 960 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the association of dietary inflammatory potential with breast cancer risk. Information collected in this study may help doctors to identify modifiable risk factors, screen high risk patients early, improve prevention strategies, and provide timely intervention for early therapeutic management as needed.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the association of dietary inflammatory potential (measured by Empirical Dietary Inflammatory Pattern \[EDIP\] score) at baseline using Diet History Questionnaire III (DHQIII) food frequency questionnaire (FFQ) with the incidence of breast cancer in high risk women established in the breast cancer prevention clinic at Ohio State University Comprehensive Cancer Center (OSUCCC) - James. SECONDARY OBJECTIVES: I. To evaluate changes in inflammatory potential of diet (EDIP score) from baseline FFQ and subsequently administered annually, and determine how these dietary changes relate to breast cancer risk longitudinally. II. To evaluate associations of dietary inflammatory potential (EDIP score) with measures of obesity including bone marrow index (BMI) (obesity defined as \>= 30, non-obese \< 30) and abdominal/visceral adiposity (waist-hip ratio \[WHR\] \> 0.85 or waist circumference \[WC\] \>= 80 cm in women) at baseline. III. To evaluate the association of dietary inflammatory potential (EDIP score) with mammographic breast density by breast imaging reporting and data system (BIRADS) classification at baseline. CORRELATIVE OBJECTIVES: I. To evaluate the correlation of baseline and annual inflammatory blood-based biomarkers (IL-6, hsCRP, adiponectin, leptin, insulin resistance \[Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)\]) with: a) dietary inflammatory potential (EDIP score) and b) visceral adiposity (waist-hip ratio \> 0.85 or waist circumference \>= 80 cm in women) and c) mammographic breast density by BIRADS classification at baseline and longitudinally (every year for 5 years). II. To evaluate the association of baseline circulating biomarkers (hsCRP, TNF-a, insulin resistance \[HOMA-IR\]) and breast cancer incidence longitudinally in high risk patients. EXPLORATORY OBJECTIVES: I. Describe utilization of supplemental imaging by type, including breast magnetic resonance imaging (MRI), automated breast ultrasound (ABUS) and contrasted-enhanced spectral mammography (CESM), in all enrolled women. II. Describe use of chemoprevention strategies (initiation of tamoxifen, raloxifene, aromatase inhibitor (AI), or other) in women presenting at the high risk clinic at OSUCCC-James. OUTLINE: Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10.

Conditions

• Breast Atypical Ductal Hyperplasia
• Breast Atypical Lobular Hyperplasia
• Breast Carcinoma
• Breast Lobular Carcinoma In Situ
• Breast Sclerosing Adenosis

Interventions

Type	Name	Description
PROCEDURE	Follow-Up	Undergo follow up
PROCEDURE	Physical Examination	Complete physical measurements
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2023-10-25
• Primary completion: 2035-12-31
• Completion: 2035-12-31
• First posted: 2022-01-05
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States