NCT05122000

Completed

Brain Imaging, Nutrition, and Cognition in Breast Cancer Sur...

Ohio State University Source

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Other study identifiers

Sponsor study identifier

2021C0128

Study Type

observational

Actual enrollment (reported)

30

Locations

1 country

Sites

1

Timeline

Study Start

January 18, 2022

Actual (reported)

Primary Completion

August 1, 2023

Actual (reported)

Study Completion

August 1, 2023

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: August 1, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 8, 2021
Actual (reported)
First Posted
November 16, 2021
Actual (reported)
Study Start
January 18, 2022
Actual (reported)
Primary Completion
August 1, 2023
Actual (reported)
Study Completion
August 1, 2023
Actual (reported)

Last Updated: May 14, 2025
Status Verified: May 2025
Last Update Submitted: May 8, 2025

Conditions

Breast Cancer

Keywords

ChemotherapyCognitive impairmentBreast cancer survivorDiet

Outcome Measures

Primary Outcomes (1)

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 Outcomes (8)

Assessment of Brain connectivity
one day
Assessment of Diet Quality Measures
one day
Assessment of cognition using the Hopkins Verbal Learning Test
One day
Assessment of cognition using the WAIS-IV Digit Span
One day
Assessment of cognition using the Oral Trail Making Test
One day
+3 more secondary outcomes

Eligibility Criteria

Age45 Years - 75 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

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.

You may qualify if:

Stage I-III breast cancer diagnosis

Sponsors & Collaborators

Ohio State University
Otherlead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood dried blood spots; whole blood venous blood samples

MeSH Terms

Conditions

Breast NeoplasmsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

Tonya S Orchard, PhD
Ohio State University
PRINCIPAL INVESTIGATOR

Enrollment

30 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor

Study Record Dates

First Submitted

November 8, 2021

First Posted

November 16, 2021

Study Start

January 18, 2022

Actual (reported)

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NCT05417451

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Phase 2Completed

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Primary Completion

August 1, 2023

Actual (reported)

Study Completion

August 1, 2023

Actual (reported)

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT05122000
Data provider: ClinicalTrials.gov
Source updated: 2025-05-14
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:42 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations