Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prisoners

Not able to speak and understand English

Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC

Trial population

Patients at high risk for breast cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Follow-Up

    Procedure/Surgery

    Undergo follow up

  • Physical Examination

    Procedure/Surgery

    Complete physical measurements

  • Questionnaire Administration

    Other intervention

    Complete questionnaires

Treatment groups

960 Participants
are divided into 1 treatment group
Group A: Observational (physical exam, questionnaire)3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 10 years

Secondary outcomes

1

Bone marrow index

Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).

Time frame
Up to 10 years
2

Waist-hip ratio

Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).

Time frame
Up to 10 years
3

Waist circumference

Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).

Time frame
Up to 10 years
4

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).

Time frame
Up to 10 years

Other outcomes

1

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

Time frame
Up to 12 months
2

Proportion of patients initiating chemoprevention during study follow up

Proportion of patients initiating chemoprevention within 12 months of enrollment will be summarized.

Time frame
Up to 12 months

Sponsors and contacts

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