Breast Cancer Clinical Trial

Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors

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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

80

Study ID:

NCT05048108

Recruitment Status:

Recruiting

Sponsor:

Ohio State University

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There is 1 Location for this study

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The Ohio State University
Columbus Ohio, 43210, United States More Info
Tonya S Orchard, PhD
Contact
614-292-7241
[email protected]
Kellie R Weinhold, MS
Contact
[email protected]
Tonya S Orchard, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

80

Study ID:

NCT05048108

Recruitment Status:

Recruiting

Sponsor:


Ohio State University

How clear is this clinincal trial information?

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