Skip to content

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05178498
Enrollment
960
Registered
2022-01-05
Start date
2023-10-25
Completion date
2035-12-31
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDUREFollow-Up

Undergo follow up

PROCEDUREPhysical Examination

Complete physical measurements

OTHERQuestionnaire Administration

Complete questionnaires

Sponsors

Ohio State University Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to breast cancer events during study follow upUp to 10 yearsWill 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

MeasureTime frameDescription
Bone marrow indexUp to 10 yearsWill be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Waist-hip ratioUp to 10 yearsWill be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Waist circumferenceUp to 10 yearsWill be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Mammographic breast densityUp to 10 yearsWill 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).

Countries

United States

Contacts

CONTACTThe Ohio State University Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu800-293-5066
PRINCIPAL_INVESTIGATORSagar D Sardesai, MSPH, PhD

Ohio State University Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026