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Impact of Dietary Inflammatory Potential on Breast Cancer Risk

NCT05178498 · Ohio State University Comprehensive Cancer Center
In plain English

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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria: * Age \>= 18 years * Established in the high risk clinic at OSUCCC- James (includes patients with family history of breast cancer \[BC\], known genetic predisposition, personal history of known atypia/breast lobular carcinoma in situ \[LCIS\], or prior chest wall radiation) * Patients at high risk for BC established in the surgical oncology clinic at Stefanie Spielman Comprehensive Breast Center (SSCBC), with one of the following diagnoses: Atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), sclerosing adenosis (SA), or radial scars (RS) * Able to read and understand English * Able to provide informed consent * Must consent to continued follow-up of medical records during the study period Exclusion Criteria: * Prisoners * Not able to speak and understand English * Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC
Study design
Enrollment target: 960 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-10-25
Estimated completion: 2035-12-31
Last updated: 2026-06-12
Interventions
Procedure: Follow-UpProcedure: Physical ExaminationOther: Questionnaire Administration
Primary outcomes
  • Time to breast cancer events during study follow up (Up to 10 years)
Sponsor
Ohio State University Comprehensive Cancer Center · other
Contacts & investigators
ContactThe Ohio State University Comprehensive Cancer Center · contact · OSUCCCClinicaltrials@osumc.edu · 800-293-5066
InvestigatorSagar D Sardesai, MSPH, PhD · principal_investigator, Ohio State University Comprehensive Cancer Center
All locations (1)
Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Impact of Dietary Inflammatory Potential on Breast Cancer Risk · TrialPath