Breast CancerRACIRO-3NCT05048108
Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors
An observational study of Breast Cancer and Obesity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Obesity
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Diagnosis of type 2 diabetes mellitus
- Unwillingness to complete finger prick for blood collection
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors at Risk for Cognitive Impairment
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.
- Conditions
- Breast Cancer, Obesity
- Keywords
- Chemotherapy, Cognitive impairment, Breast cancer survivor, Diet, Remote assessment
- Medical subject headings
- Breast Neoplasms, Obesity, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Secondary outcomes (4)
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.
Measured: One day
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.
Measured: One day
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.
Measured: One day
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start18 Jan 2022
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonya Orchard, Ohio State University Comprehensive Cancer Center
- Investigators
- Tonya S Orchard, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048108
- Sponsor's protocol ID
- OSU-21100
- Acronym
- RACIRO-3
- Status last verified
- Jun 2025
- First submitted
- 30 Aug 2021
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Assessment of Cognition, Insulin Resistance and Omega-3 Fatty Acid Biomarkers in Breast Cancer Survivors at Risk for Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05048108
- Acronym / sponsor ID
- RACIRO-3 / OSU-21100
- Conditions
- Breast Cancer, Obesity
- Keywords
- Chemotherapy, Cognitive impairment, Breast cancer survivor, Diet, Remote assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Diagnosis of type 2 diabetes mellitus
- Unwillingness to complete finger prick for blood collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine number of participants with insulin resistance via HOMA-IR from remote dried blood spot collection
Time frame: One day
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.
4 secondary outcomes
Remote assessment of cognition using the Hopkins Verbal Learning Test
Time frame: One day
Remote assessment of cognition using the WAIS-IV Digit Span
Time frame: One day
Remote assessment of cognition using the Oral Trail Making Test
Time frame: One day
Remote assessment of cognition using the COWA Test
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tonya S Orchard, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Obesity, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine number of participants with insulin resistance via HOMA-IR from remote dried blood spot collection (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.