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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05178498.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Sagar D. Sardesai
Phone: 614-293-6401
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 Body Mass 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.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorSagar D. Sardesai