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NCT Number: NCT06582615

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

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 symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression.

Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions.

Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely.

Participants will:

* Be randomized to MIND or GHC interventions * Complete all study measures remotely (by online questionnaires, virtual visits and mail ) * Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks * Be sent some of the key foods in the MIND eating plan during the MIND intervention * Be contacted for follow-up measures 6 months after interventions

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Key information

Conditions

Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Triple-Negative Breast Carcinoma

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale University, New Haven, Connecticut, United States

Loading trial locations.

About this study

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) control to reduce CRCI and associated neuropsychological symptoms in 60 racially and ethnically diverse women with clinical stage II-III TNBC.

II. Evaluate the sustainability of dietary changes and outcome measures 6-months post-intervention.

EXPLORATORY OBJECTIVE:

I. Explore underlying mechanisms of the MIND-BC diet on CRCI and effects of early versus later participation in the dietary intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.

ARM II: Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.

After completion of study intervention, patients are followed up at 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo dried blood spot collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

cognitive assessment

Procedure

Ancillary studies

Dietary Intervention

Other

Receive MIND counseling sessions

Other names: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Medical Device Usage and Evaluation

Other

Wear a Fitbit

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score

    Time frame: Baseline 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.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • American Institute for Cancer Research

Registry information

Official study title

Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer

Acronym: MIND-TNBC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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