Clinical trial NCT05178498: Impact of Dietary Inflammatory Potential on Breast Cancer Risk
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Atypical Ductal Hyperplasia
Breast Atypical Lobular Hyperplasia
Breast Carcinoma
Breast Lobular Carcinoma In Situ
Breast Sclerosing Adenosis
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at high risk for breast cancer

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to breast cancer events during study follow up
timeFrame: Up to 10 years
Secondary outcomes:
measure: Bone marrow index
timeFrame: Up to 10 years
measure: Waist-hip ratio
timeFrame: Up to 10 years
measure: Waist circumference
timeFrame: Up to 10 years
measure: Mammographic breast density
timeFrame: Up to 10 years
Other outcomes:
measure: 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
timeFrame: Up to 12 months
measure: Proportion of patients initiating chemoprevention during study follow up
timeFrame: Up to 12 months
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Sagar D Sardesai, MSPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: