Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-25

Study Completion Date

2035-12-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Follow-Up

Intervention Type PROCEDURE

Undergo follow up

Physical Examination

Intervention Type PROCEDURE

Complete physical measurements

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Follow-Up

Undergo follow up

Intervention Type PROCEDURE

Physical Examination

Complete physical measurements

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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Active Follow-up Clinical Signs Follow-up CLSFUP Follow Up follow_up Followed Followup Assessment General Examination Physical Physical Assessment Physical Exam physical_exam

Eligibility Criteria

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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