NCT05048108Completed
Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors
Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors at Risk for Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 65 (actual)
- First submitted
- 30 Aug 2021
- Start date
- Jan 2022
- Primary completion date
- Nov 2023
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Diseases
- Obesity
- NCT number
- NCT05048108
What you commit to
- Study type: Observational
- Participants enrolled: 65
- From Jan 2022 to the primary completion date, Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of type 2 diabetes mellitus
Other
- Unwillingness to complete finger prick for blood collection
Who the study is looking for
- 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
Age in the registry: 45 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ohio State University Comprehensive Cancer Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.