Nutrition intervention for women with triple negative breast cancer
Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer
This study is testing if following a healthy eating plan called the MIND diet can help women with triple negative breast cancer feel better mentally and physically while they are undergoing chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT06582615 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if a healthy eating pattern known as the MIND diet can alleviate cancer-related cognitive impairment and other symptoms in women undergoing chemotherapy for stage II-III triple negative breast cancer. Participants will be randomly assigned to either the MIND diet intervention or a general health coaching program, with both groups receiving remote counseling sessions. The study will evaluate the effectiveness of the MIND diet in improving memory, mental function, fatigue, sleep quality, anxiety, and depression over a 12-week period, followed by a 6-month follow-up. The trial also seeks to explore the sustainability of dietary changes and the underlying mechanisms of the diet's effects on cognitive impairment.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-65 with newly diagnosed stage II-III triple negative breast cancer who are starting or have recently started neoadjuvant chemotherapy.
Not a fit: Patients with a history of cognitive impairment or those currently following a healthy eating pattern similar to the MIND diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive function and overall quality of life for women undergoing treatment for triple negative breast cancer.
How similar studies have performed: While the specific approach of the MIND diet for this population is novel, similar dietary interventions have shown promise in improving cognitive function in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
New Haven, Connecticut and 1 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Tonya Orchard, PhD — Ohio State University Comprehensive Cancer Center
- 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.