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OpenTrials
Completed

NCT Number: NCT05122000

Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Evaluate feasibility through recruitment and retention

    Time frame: Two years

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

Secondary outcomes

  1. Assessment of Brain connectivity

    Time frame: one day

    Assess brain connectivity from MRI images

  2. Assessment of Diet Quality Measures

    Time frame: one day

    Assess diet quality measures from an electronic food frequency questionnaire

  3. Assessment of cognition using the Hopkins Verbal Learning Test

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: One day

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

  8. Assessment of presence of CRCI symptoms

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: BRINC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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