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Nutrition Intervention for Triple Negative Breast Cancer

This study, called "Food for Thought," is looking at whether a healthy eating plan called the MIND diet can help women with newly diagnosed stage II or III triple-negative breast cancer (TNBC) who are undergoing active treatment. Researchers want to see if the MIND diet can reduce "chemobrain" (cancer-related cognitive impairment) and other common symptoms like fatigue, sleep problems, anxiety, and depression. You would be between 40 and 65 years old, female, and have started cancer treatment for TNBC within the last 12 months. The study aims to enroll 60 participants and will measure changes in memory and mental function to see if the MIND diet is effective.

Study design
This is an interventional study where participants are randomly assigned to one of two groups: either the MIND diet counseling or general health coaching. The study plans to enroll 60 women.
What's involved
You would participate in weekly or bi-weekly counseling sessions for 12 weeks, follow a personalized diet, and wear a Fitbit. You would also provide dried blood spot samples.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up 6 months after the 12-week intervention period to assess the lasting effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06582615

Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer

Recruiting
NAAges 40–65InterventionalSupportive care
Ohio State University Comprehensive Cancer Center
~60 participants
Updated 2025-12-11 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCognitive AssessmentDietary InterventionMedical Device Usage and EvaluationQuestionnaire Administration

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score
Measured over Baseline up to 6 months post-intervention

Conditions

Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
Triple-Negative Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
Connecticut1
Ohio1

Study leadership

  • Tonya Orchard, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State University Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span scoreBaseline up to 6 months post-intervention

    Analyses of change in WAIS-IV test scores will be based on a linear or generalized linear mixed effects regression model, as appropriate. Timepoint, treatment assignment, and their interaction will be included as fixed effects, and a subject-level random intercept effect will be included to account for correlation of repeated measurements from the same subject. Pathological complete response and baseline measurements of the outcome variables will also be included as fixed effects to improve precision, as will any demographic variables that are substantially imbalanced at baseline. Will report descriptive statistics, and when applicable, comparisons between randomized groups.