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

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 Overview

• Status: Recruiting
• Conditions: Breast Carcinoma; Breast Atypical Ductal Hyperplasia; Breast Atypical Lobular Hyperplasia; Breast Lobular Carcinoma In Situ; Breast Sclerosing Adenosis
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Follow-Up; Procedure: Physical Examination

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.

• Study Type: Observational
• Enrollment (Estimated): 960

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Sagar D. Sardesai, MSPH, PhD; Phone Number: 614-293-6401; Email: Sagar.Sardesai@osumc.edu
      • Principal Investigator: Sagar D. Sardesai, MSPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients at high risk for breast cancer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational (physical exam, questionnaire); Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10.	Other: Questionnaire Administration; Complete questionnaires; Procedure: Follow-Up; Undergo follow up; Other Names: Active Follow-up; Clinical Signs Follow-up; CLSFUP; Follow Up; follow_up; Followed; Followup; Procedure: Physical Examination; Complete physical measurements; Other Names: Assessment; General Examination; Physical; Physical Assessment; Physical Exam; physical_exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to breast cancer events during study follow up	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables). To assess the association of baseline Empirical Dietary Inflammatory pattern (EDIP) scores with breast cancer incidence, Cox proportional hazards regression will be used to estimate the hazard ratio (HR) and its 95% confidence interval (CI).	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone marrow index	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).	Up to 10 years
Waist-hip ratio	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).	Up to 10 years
Waist circumference	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).	Up to 10 years
Mammographic breast density	Will be measured by breast imaging reporting and data system. Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).	Up to 10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who received at least 1 supplemental screening breast by breast magnetic resonance imaging, automated breast ultrasound, and contrasted-enhanced spectral mammography during study follow up		Up to 12 months
Proportion of patients initiating chemoprevention during study follow up	Proportion of patients initiating chemoprevention within 12 months of enrollment will be summarized.	Up to 12 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Sagar D Sardesai, MSPH, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Skin Diseases; Breast Diseases; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Carcinoma; Breast Neoplasms; Carcinoma in Situ; Hyperplasia; Carcinoma, Intraductal, Noninfiltrating; Carcinoma, Lobular
• Other Study ID Numbers: OSU-21065; NCI-2021-03342 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No