Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors

NCT ID: NCT05122000

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-18
• Study Completion Date: 2023-08-01

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Tonya Orchard

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tonya S Orchard, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2021C0128

Identifier Type: -

Identifier Source: org_study_id