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

NCT06582615 | Recruiting DMC

• 2 other identifiers: OSU-23384NCI-2024-05451
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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 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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline up to 6 months post-intervention

Study Arms (2)

Arm I (MIND-TNBC counseling)

EXPERIMENTAL

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.

Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Dietary Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Arm II (general health recommendations counseling)

ACTIVE COMPARATOR

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.

Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Dietary Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration

Interventions

Biospecimen Collection PROCEDURE

Undergo dried blood spot collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (MIND-TNBC counseling); Arm II (general health recommendations counseling)

Cognitive Assessment PROCEDURE

Ancillary studies

Arm I (MIND-TNBC counseling); Arm II (general health recommendations counseling)

Dietary Intervention OTHER

Receive MIND counseling sessions

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm I (MIND-TNBC counseling)

Medical Device Usage and Evaluation OTHER

Wear a Fitbit

Arm I (MIND-TNBC counseling); Arm II (general health recommendations counseling)

Questionnaire Administration OTHER

Ancillary studies

Arm I (MIND-TNBC counseling); Arm II (general health recommendations counseling)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• American Institute for Cancer Research: collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06519, United States

RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Specimen Handling; Mental Status and Dementia Tests; Diet Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Nutrition Therapy; Therapeutics

Study Officials

• Tonya Orchard, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel design with optional cross-over of the control group to the treatment group after 6-month follow-up.

Study Record Dates

• First Submitted: August 30, 2024
• First Posted: September 3, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (2)