Anatomic Stage II Breast Cancer AJCC v8MIND-TNBCNCT06582615
Food for Thought - A Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
A study testing Biospecimen Collection, Cognitive Assessment and Dietary Intervention in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
- What is being tested?
- Biospecimen Collection, Cognitive Assessment and Dietary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
The Ohio State University Comprehensive Cancer Center contact
United States2 sites, 2 recruiting
- Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Tonya Orchard, PhD, 614-292-7241, Orchard.6@osu.edu
Tonya Orchard
- Recruiting
Yale University
New Haven, Connecticut, 06519
Maryam Lustberg, MD, MPH, 203-200-2328, maryam.lustberg@yale.edu
About this study
Official title: Food for Thought - Pilot Study of a MIND Diet Intervention in 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.
Read more
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
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
- Being tested
- Biospecimen Collection, Cognitive Assessment, Dietary Intervention, Medical Device Usage and Evaluation, Questionnaire Administration
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo dried blood spot collection
Cognitive AssessmentProcedure or surgery
Ancillary studies
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive MIND counseling sessions
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Follow a personalized diet
Dietary InterventionOther
Also called Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions
Receive general health recommendations counseling sessions
Medical Device Usage and EvaluationOther
Wear a Fitbit
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Biospecimen Collection; Procedure: Cognitive Assessment; Other: Dietary Intervention; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start28 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage II Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel design with optional cross-over of the control group to the treatment group after 6-month follow-up.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Institute for Cancer Research
- Responsible party
- Principal investigator, Tonya Orchard, Ohio State University Comprehensive Cancer Center
- Investigators
- Tonya Orchard, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582615
- Sponsor's protocol ID
- OSU-23384
- Other IDs
- NCI-2024-05451
- Acronym
- MIND-TNBC
- Status last verified
- Dec 2025
- First submitted
- 30 Aug 2024
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06582615
- Acronym / sponsor ID
- MIND-TNBC / OSU-23384
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Institute for Cancer Research
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel design with optional cross-over of the control group to the treatment group after 6-month follow-up.
| Arm | Type | Receives |
|---|---|---|
| Arm I (MIND-TNBC counseling) | Experimental | Procedure: Biospecimen Collection, Procedure: Cognitive Assessment, Other: Dietary Intervention, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients 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 (general health recommendations counseling) | Active comparator | Procedure: Biospecimen Collection, Procedure: Cognitive Assessment, Other: Dietary Intervention, Other: Medical Device Usage and Evaluation, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo dried blood spot collection | Procedure or surgery | Arm I (MIND-TNBC counseling), Arm II (general health recommendations counseling) |
| Cognitive AssessmentAncillary studies | Procedure or surgery | Arm I (MIND-TNBC counseling), Arm II (general health recommendations counseling) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive MIND counseling sessions | Other | Arm I (MIND-TNBC counseling) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsFollow a personalized diet | Other | Arm I (MIND-TNBC counseling) |
| Dietary InterventionAlso: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition InterventionsReceive general health recommendations counseling sessions | Other | Arm II (general health recommendations counseling) |
| Medical Device Usage and EvaluationWear a Fitbit | Other | Arm I (MIND-TNBC counseling), Arm II (general health recommendations counseling) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (MIND-TNBC counseling), Arm II (general health recommendations counseling) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- The JameslineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The Ohio State University Comprehensive Cancer Center contact
Tonya Orchard, PhD principal investigator
Ohio State University Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biospecimen Collection, Cognitive Assessment and Dietary Intervention in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact The Ohio State University Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score (time frame: Baseline up to 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.