Clinical trial NCT05122000: Brain Imaging, Nutrition, and Cognition in Breast Cancer Survivors
Official title: How Integrity of the Connectome and Nutritional Status Change Brain Function in Breast Cancer Patients Undergoing Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Chemotherapy
Cognitive impairment
Breast cancer survivor
Diet
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate feasibility through recruitment and retention
timeFrame: Two years
Secondary outcomes:
measure: Assessment of Brain connectivity
timeFrame: one day
measure: Assessment of Diet Quality Measures
timeFrame: one day
measure: Assessment of cognition using the Hopkins Verbal Learning Test
timeFrame: One day
measure: Assessment of cognition using the WAIS-IV Digit Span
timeFrame: One day
measure: Assessment of cognition using the Oral Trail Making Test
timeFrame: One day
measure: Assessment of cognition using the COWA Test
timeFrame: One day
measure: Assessment of cognition using the Boston Naming Test
timeFrame: One day
measure: Assessment of presence of CRCI symptoms
timeFrame: One day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tonya S Orchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: