Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Recruiting

• Conditions: Breast Sclerosing Adenosis; Breast Carcinoma; Breast Lobular Carcinoma In Situ; Breast Atypical Ductal Hyperplasia; Breast Atypical Lobular Hyperplasia
• Interventions: Procedure: Follow-Up; Procedure: Physical Examination; Other: Questionnaire Administration

• Registration Number: NCT05178498
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2021-12-16
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Study Start: 2023-10-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Primary Completion: 2035-12-31
• Study Completion: 2035-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 960

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (physical exam, questionnaire)	Questionnaire Administration	Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10.
Observational (physical exam, questionnaire)	Physical Examination	Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10.
Observational (physical exam, questionnaire)	Follow-Up	Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10.

Primary Outcome Measures

Name	Time	Method
Time to breast cancer events during study follow up	Up to 10 years	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).

Secondary Outcome Measures

Name	Time	Method
Waist-hip ratio	Up to 10 years	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Mammographic breast density	Up to 10 years	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).
Bone marrow index	Up to 10 years	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Waist circumference	Up to 10 years	Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States