Diet intervention to support brain health in women with breast cancer
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05984888 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women with stage II-IV hormone receptor-positive breast cancer who are starting systemic therapies.
Not a fit: Patients with a history of cognitive impairment or those diagnosed with triple negative breast cancer may not benefit from this study.
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 performed: Similar dietary interventions have shown promise in improving cognitive outcomes in other populations, suggesting potential for success in this novel application.
Eligibility criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.