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Spots Global Cancer Trial Database for Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors

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Trial Identification

Brief Title: 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 ID: NCT05048108

Interventions

Study Description

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.

Detailed Description:

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

The Ohio State University, Columbus, Ohio, United States

Contact Details

Name: Tonya S Orchard, PhD

Affiliation: Ohio State University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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