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

Breast Cancer Clinical Trial

— RACIRO-3  

Official title:

Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors at Risk for Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048108
• Other study ID #: 2021C0102
• Status: Recruiting
• Start date: January 18, 2022
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Ohio State University
• Contact: Tonya S Orchard, PhD
• Phone: 614-292-7241
• Email: orchard.6[@]osu.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Insulin Resistance
• Obesity

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Remote assessment of cognition using the Hopkins Verbal Learning Test	Assess cognition remotely through a zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning.	One day
Secondary	Remote assessment of cognition using the WAIS-IV Digit Span	Assess cognition remotely through a zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory.	One day
Secondary	Remote assessment of cognition using the Oral Trail Making Test	Assess cognition remotely through a zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention.	One day
Secondary	Remote assessment of cognition using the COWA Test	Assess cognition remotely through a zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function.	One day