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RACIRO-3
Sponsor study identifier
observational
65
1 country
1
Study Start
January 18, 2022
Actual (reported)Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2021
Actual (reported)September 17, 2021
Actual (reported)January 18, 2022
Actual (reported)November 30, 2023
Actual (reported)November 30, 2023
Actual (reported)Determine number of participants with insulin resistance via HOMA-IR from remote dried blood spot collection
Homeostatic model assessment for insulin resistance (HOMA-IR) is calculated by fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Insulin and glucose measures will be obtained from the dried blood spot collection.
One day
Remote assessment of cognition using the Hopkins Verbal Learning Test
One day
Remote assessment of cognition using the WAIS-IV Digit Span
One day
Remote assessment of cognition using the Oral Trail Making Test
One day
Remote assessment of cognition using the COWA Test
One day
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.
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Whole blood dried blood spots
Tonya S Orchard, PhD
Ohio State University
65 participants (actual enrollment reported by the registry).
First Submitted
August 30, 2021
First Posted
September 17, 2021
Study Start
January 18, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 30, 2023
Actual (reported)Study Completion
November 30, 2023
Actual (reported)Last Updated
July 8, 2025
Record last verified: 2025-06
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.
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