BRINC: Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05122000
Collaborator
(none)
30
1
25.4
1.2

Study Details

Study Description

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 45-65) who have recently completed chemotherapy treatment within 3-6 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    How Integrity of the Connectome and Nutritional Status Change Brain Function in Breast Cancer Patients Undergoing Chemotherapy
    Actual Study Start Date :
    Jan 18, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Evaluate feasibility through recruitment and retention [Two years]

      Retention is determined by numbers of participants who drop out from the study versus compared to those who complete the study.

    Secondary Outcome Measures

    1. Assessment of Brain connectivity [one day]

      Assess brain connectivity from MRI images

    2. Assessment of Diet Quality Measures [one day]

      Assess diet quality measures from an electronic food frequency questionnaire

    3. Assessment of cognition using the Hopkins Verbal Learning Test [One day]

      Assess cognition by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning.

    4. Assessment of cognition using the WAIS-IV Digit Span [One day]

      Assess cognition by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory.

    5. Assessment of cognition using the Oral Trail Making Test [One day]

      Assess cognition by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention.

    6. Assessment of cognition using the COWA Test [One day]

      Assess cognition by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function.

    7. Assessment of cognition using the Boston Naming Test [One day]

      Assess cognition by using the Boston Naming Test Short Form, a brief test of language.

    8. Assessment of presence of CRCI symptoms [One day]

      Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Stage I-III breast cancer diagnosis

    • Between 3-6 months post-treatment with adjuvant 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 alcohol or substance use disorders, or any psychoactive medication use within the past 4 months

    • Current diagnosis of dementia, psychosis or major depressive disorders

    • Concurrent other malignancy or metastatic malignancy of any kind

    • Unable to give informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonya Orchard, Associate Professor, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT05122000
    Other Study ID Numbers:
    • 2021C0128
    First Posted:
    Nov 16, 2021
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tonya Orchard, Associate Professor, Ohio State University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 18, 2022