Diet intervention to support brain health in women with breast cancer
Official title: Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
Run by Ohio State University Comprehensive Cancer Center · NCT05984888 · Data updated 2026-11-12
This study is testing if following the MIND diet can help women with hormone receptor-positive breast cancer feel better mentally while they are receiving treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 75 Years |
| Sex | Women only |
| Enrollment | 43 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | October 26, 2023 |
| Main results expected | June 2027 |
| Study ends | December 2027 |
| Registry record updated | October 3, 2025 |
| Trial ID | NCT05984888 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are post-menopausal women with stage II-IV hormone receptor-positive breast cancer who are starting systemic therapies.
✕Probably not a fit
Patients with a history of cognitive impairment or those diagnosed with triple negative breast cancer may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study investigates the effects of the MIND diet on cognitive function in women undergoing active treatment for breast cancer. The MIND diet emphasizes anti-inflammatory nutrients while limiting unhealthy foods, aiming to mitigate cognitive decline associated with cancer therapies. Participants will be randomized into either the MIND diet intervention group or a general health curriculum group to assess the impact on their cognitive outcomes. The study focuses on women diagnosed with hormone receptor-positive breast cancer who are starting systemic therapies.
Why it matters
Potential benefit: If successful, this intervention could improve cognitive function and quality of life for women undergoing treatment for breast cancer.
How similar studies have gone: Similar dietary interventions have shown promise in improving cognitive outcomes in other populations, suggesting potential for success in this novel application.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Stage II-IV hormone receptor+, breast cancer diagnosis * Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy) * Within 4 weeks before or 12 weeks after starting initial systemic therapies (e.g. chemotherapy, targeted therapies such as CDK4/6 inhibitors, endocrine therapy) * Ability to access and use internet resources, including video calls using Zoom platform * English speaking Exclusion Criteria: * History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment * MIND diet score \>8 * Unwilling/unable to eat \>2 types of MIND food * Receiving insulin therapy for diabetes * Diagnosis of triple negative breast cancer * Unable to give informed consent.
Where it's running
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Tonya S Orchard, PhD — Ohio State University
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.