Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors (BRINC)

How Integrity of the Connectome and Nutritional Status Change Brain Function in Breast Cancer Patients Undergoing Chemotherapy

Up to 78% of women diagnosed with breast cancer experience impairments in their cognitive function (e.g., frequent forgetfulness, slow processing speeds, and difficulties in concentration, multitasking and/or word retrieval) in the course of cancer treatment. These cognitive impairments (CI) have negative effects on patients' social relationships, overall life satisfaction, and treatment adherence. Dietary intake may be an important factor in mitigating risk of CI that breast cancer patients experience. Several studies have suggested that dietary intake of specific nutrients and foods (e.g., carotenoids, B-vitamin, and omega-3 fatty acids rich foods) can be helpful to decrease the severity of cancer-related cognitive impairment (CRCI). High-quality dietary patterns can be also helpful to protect white matter volume and its integrity; damage to and changes in white matter contributes to CRCI. However, despite the high incidence of CRCI in breast cancer patients, very little is known about etiology of CRCI. Thus, the purpose of this observational study with cross-sectional design is to examine the relationships of diet with brain structural and functional outcomes of breast cancer patients. The study will aim to enroll 30 female postmenopausal breast cancer survivors (age 45-75) who have recently completed chemotherapy treatment within 3-12 months from study enrollment. Participants will complete study questionnaires online, and will have an in-person study visit to complete a functional magnetic resonance imagine (MRI) scan, cognitive testing, and blood sample collection via fingerstick and venous blood draw. It is expected that this study will advance the field's understanding and ability to early assess, manage, and prevent CRCI.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer survivors from the Central Ohio area, including those who were seen at The Ohio State University Wexner Medical Center James Cancer Hospital for cancer treatment.

Description

Inclusion Criteria:

• Stage I-III breast cancer diagnosis
• Between 3-12 months post-treatment with anthracycline or taxane-based chemotherapy
• Postmenopausal (at least 12 months without menses; OR on ovarian suppression medication; OR status post oophorectomy)
• English speaking

Exclusion Criteria:

• Women who have permanent ferromagnetic metal in the body, a pacemaker, or have severe claustrophobia
• Women who are pregnant or breastfeeding
• Diagnosis of dementia, psychosis, alcohol or substance use disorders
• Concurrent other malignancy or metastatic malignancy of any kind
• Unable to give informed consent.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate feasibility through recruitment and retention	Retention is determined by numbers of participants who drop out from the study versus compared to those who complete the study.	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Brain connectivity	Assess brain connectivity from MRI images	one day
Assessment of Diet Quality Measures	Assess diet quality measures from an electronic food frequency questionnaire	one day
Assessment of cognition using the Hopkins Verbal Learning Test	Assess cognition by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning.	One day
Assessment of cognition using the WAIS-IV Digit Span	Assess cognition by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory.	One day
Assessment of cognition using the Oral Trail Making Test	Assess cognition by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention.	One day
Assessment of cognition using the COWA Test	Assess cognition by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function.	One day
Assessment of cognition using the Boston Naming Test	Assess cognition by using the Boston Naming Test Short Form, a brief test of language.	One day
Assessment of presence of CRCI symptoms	Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function.	One day

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Tonya S Orchard, PhD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 8, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Diet; Chemotherapy; Cognitive impairment; Breast cancer survivor
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021C0128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No