Status:
RECRUITING
Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
American Institute for Cancer Research
Conditions:
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Eligibility:
FEMALE
40-65 years
Phase:
NA
Brief Summary
The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other s...
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet intervention (MIND-Breast Cancer \[BC\]) versus (vs.) general health curriculum (GHC) contro...
Eligibility Criteria
Inclusion
- Age 40-65 years
- Female with stage I-III triple negative breast cancer
- Less than or equal to 12 months from starting initial systemic cancer treatment (e.g. chemotherapy, targeted therapy, immunotherapy) for TNBC
- Ability to access and use internet resources, including video calls using Zoom platform
- English speaking
Exclusion
- History of dementia, stroke, traumatic brain injury, brain metastasis or other conditions that could lead to cognitive impairment
- Current healthy eating pattern reflected by high MIND diet score (e.g. \>12)
- Unwilling/unable to eat \> 2 types of MIND food (e.g. avoids \& \> 2 categories or food groups such as leafy greens, olive oil and non-fried fish)
- Currently pregnant
- Unable to give informed consent
Key Trial Info
Start Date :
October 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06582615
Start Date
October 28 2024
End Date
December 31 2026
Last Update
December 11 2025
Active Locations (2)
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1
Yale University
New Haven, Connecticut, United States, 06519
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210