Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Breast Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05178498
• Other study ID #: OSU-21065
• Secondary ID: NCI-2021-03342
• Status: Not yet recruiting
• Start date: September 30, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 885
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Atypical Ductal Hyperplasia
• Breast Atypical Lobular Hyperplasia
• Breast Carcinoma
• Breast Carcinoma In Situ
• Breast Lobular Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Intraductal, Noninfiltrating
• Carcinoma, Lobular
• Hyperplasia

Intervention

Procedure:
• Follow-Up
Undergo follow up
• Physical Examination
Complete physical measurements

Other:
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   The Jamesline