Breast CancerBRINCNCT05122000
Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors
An observational study of Breast Cancer, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Keywords
- Chemotherapy, Cognitive impairment, Breast cancer survivor, Diet
- Medical subject headings
- Breast Neoplasms, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Secondary outcomes (8)
Assessment of Brain connectivity
Assess brain connectivity from MRI images
Measured: one day
Assessment of Diet Quality Measures
Assess diet quality measures from an electronic food frequency questionnaire
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start18 Jan 2022
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonya Orchard, Ohio State University
- Investigators
- Tonya S Orchard, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122000
- Sponsor's protocol ID
- 2021C0128
- Acronym
- BRINC
- Status last verified
- May 2025
- First submitted
- 8 Nov 2021
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Integrity of the Connectome and Nutritional Status Change Brain Function in Breast Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT05122000
- Acronym / sponsor ID
- BRINC / 2021C0128
- Conditions
- Breast Cancer
- Keywords
- Chemotherapy, Cognitive impairment, Breast cancer survivor, Diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Assessment of Brain connectivity
Time frame: one day
Assessment of Diet Quality Measures
Time frame: one day
Assessment of cognition using the Hopkins Verbal Learning Test
Time frame: One day
Assessment of cognition using the WAIS-IV Digit Span
Time frame: One day
Assessment of cognition using the Oral Trail Making Test
Time frame: One day
Assessment of cognition using the COWA Test
Time frame: One day
Assessment of cognition using the Boston Naming Test
Time frame: One day
Assessment of presence of CRCI symptoms
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonya S Orchard, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate feasibility through recruitment and retention (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.