Nutrition intervention for women with triple negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.