Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors

Breast Cancer Clinical Trial

— BRINC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122000
• Other study ID #: 2021C0128
• Status: Completed
• Start date: January 18, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of Brain connectivity	Assess brain connectivity from MRI images	one day
Secondary	Assessment of Diet Quality Measures	Assess diet quality measures from an electronic food frequency questionnaire	one day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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