Clinical trial NCT05048108: Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors
Official title: Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors At Risk for Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Obesity
Keywords: Chemotherapy
Cognitive impairment
Breast cancer survivor
Diet
Remote assessment
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 65
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: Majority of breast cancer survivors are overweight or obese at time of diagnosis, putting them at increased risk for insulin resistance and Type 2 Diabetes Mellitus (T2DM). Women with insulin resistance at time of breast cancer diagnosis often have larger tumors, later stages of cancer and worse prognosis. Additionally, chemotherapy often leads to increases in insulin resistance and cognitive impairment. Many cancer survivors experience memory and brain function decline following chemotherapy that can last for years, and insulin resistance may contribute to worse cognitive outcomes in cancer survivors. Omega-3 polyunsaturated fatty acids (PUFAs) are anti-inflammatory nutrients that may help reduce insulin resistance and negative cognitive outcomes from cancer treatments. The purpose of this observational study with cross-sectional design is to investigate the relationship of omega-3 PUFAs with insulin resistance and cognitive function in obese breast cancer survivors. Due to the global pandemic caused by the coronavirus disease of 2019 (COVID-19), this study will be conducted entirely remotely using electronic data collection and remote finger-stick blood sample collection. The study will aim to enroll 80 racially and ethnically diverse female breast cancer survivors (age 45-75) who are postmenopausal, and 1 to 4 years post breast cancer diagnosis. Participants will complete study questionnaires online, and some cognitive tests will be completed through zoom sessions with trained study personnel. Participants will be mailed kits with thorough instructions to complete fingerstick blood sample collections and mail them back to the research lab. Upon receipt of blood samples and completion of all study questionnaires, participation will be complete.


Eligibility criteria: Inclusion Criteria:

* Stage I-III breast cancer diagnosis
* Between 1-4 years post-breast cancer diagnosis
* Postmenopausal (at least 1 year post-menses)
* Ability to access and use internet resources, including Zoom video calls
* English speaking

Exclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Unwillingness to complete finger prick for blood collection

Primary outcomes:
measure: Determine number of participants with insulin resistance via HOMA-IR from remote dried blood spot collection
timeFrame: One day
Secondary outcomes:
measure: Remote assessment of cognition using the Hopkins Verbal Learning Test
timeFrame: One day
measure: Remote assessment of cognition using the WAIS-IV Digit Span
timeFrame: One day
measure: Remote assessment of cognition using the Oral Trail Making Test
timeFrame: One day
measure: Remote assessment of cognition using the COWA Test
timeFrame: One day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tonya S Orchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: