Recruiting

Nutrition Intervention

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06582615

Conditions

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cognitive Assessment

Dietary Intervention

Dietary Intervention

Dietary Intervention

Study Details

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

Anatomic Stage III Breast Cancer AJCC v8

Triple-Negative Breast Carcinoma

Study ID

NCT06582615

Start date

Oct 28, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (MIND-TNBC counseling)

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.

active comparator: Arm II (general health recommendations counseling)

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.

Interventions

Biospecimen Collection

Undergo dried blood spot collection

Cognitive Assessment

Ancillary studies

Dietary Intervention

Receive MIND counseling sessions

Dietary Intervention

Follow a personalized diet

Dietary Intervention

Receive general health recommendations counseling sessions

Medical Device Usage and Evaluation

Wear a Fitbit

Questionnaire Administration

Ancillary studies

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 ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Maryam Lustberg, MD, MPH

203-200-2328maryam.lustberg@yale.edu

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Tonya Orchard, PhD

614-292-7241Orchard.6@osu.edu

Principal Investigator:

Tonya Orchard

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Dec 11, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2025-12-11.