Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer (MIND-BC)

September 29, 2025 updated by: Tonya Orchard, Ohio State University Comprehensive Cancer Center

Protecting the Brain From Toxic Side Effects of Chemotherapy: a Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer

Breast cancer (BC) is the most frequently diagnosed cancer in women. Systemic cancer treatments are an important contributor to dramatic improvements in the long-term survival of women with BC. However, cancer treatment can lead to cognitive impairment and declines in quality of life in women with BC. Many cancer survivors experience memory and brain function decline following chemotherapy which can last for years. A newer diet pattern, Mediterranean-DASH [Dietary Approaches to Stop Hypertension] Intervention for Neurodegenerative Delay (MIND), was shown to help with protecting brain functions. The MIND diet is high in anti-inflammatory nutrients (e.g., omega-3 polyunsaturated fatty acids (PUFAs), carotenoids, B-vitamins, and polyphenols) and limits the intake of brain-unhealthy foods (i.e., butter/margarine, cheese, red meat, fried foods, pastries, and sweets), which may help alleviate negative cognitive outcomes from cancer treatments. This randomized controlled trial aims to investigate the effect of the MIND diet on cognitive functions in women with invasive BC starting systemic therapies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tonya S Orchard, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage II-IV hormone receptor+, breast cancer diagnosis
  • Post-menopausal (defined as at least 1-year post menses, on ovarian suppression medication, or s/p oophorectomy)
  • Within 4 weeks before or 12 weeks after starting initial systemic therapies (e.g. chemotherapy, targeted therapies such as CDK4/6 inhibitors, endocrine therapy)
  • 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
  • MIND diet score >8
  • Unwilling/unable to eat >2 types of MIND food
  • Receiving insulin therapy for diabetes
  • Diagnosis of triple negative breast cancer
  • Unable to give informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIND-BC Intervention Group
Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.
Behavioral: MIND Diet Intervention Group
Participants will receive individually tailored nutrition counseling on adopting the MIND diet pattern from a registered dietitian nutritionist (RDN) for a total of 8 sessions spanning 12 weeks. After completing the counseling sessions participants will be followed up 6 months later to collect additional questionnaires and assessments.
Active Comparator: General Health Curriculum (GHC) Control
Sessions of non-diet related health topic education.
Behavioral: General Health Curriculum (GHC) Group
Participants will meet with trained study staff for 8 sessions spanning 12 weeks covering content on non-diet related health topics. After these sessions, participants will be followed up 6 months later to collect additional questionnaires and assessments. Once 6-month follow-up has been completed, participants will be offered to receive the MIND diet intervention offered in the MIND Diet Intervention Group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)
Time Frame: One day
Assess cognition remotely through a Zoom session by using the Hopkins Verbal Learning Test (HVLT), a brief cognitive test of episodic memory and verbal learning. The HVLT is broken down into three trials of free-recall from a 12-item list of words, followed by a period of time then a fourth recall trial. Finally, the test ends with a recognition task. For all trials, the maximum score is 12 with higher scores indicating better cognition.
One day
Remote assessment of cognition using the WAIS-IV Digit Span
Time Frame: One day
Assess cognition remotely through a Zoom session by using the Wechsler Adult Intelligence Scale (WAIS)-IV Digit Span, a cognitive test of attention and working memory. The WAIS-IV Digit Span is comprised of three individual tests: Digit Span Forward, Digit Span Backward, and Digit Span Sequence. A total potential score of 48 with higher scores indicating better cognition.
One day
Remote assessment of cognition using the Oral Trail Making Test
Time Frame: One day
Assess cognition remotely through a Zoom session by using the Oral Trail Making Test (TMT), a brief cognitive test of executive function and attention. The OTMT is divided into part A and part B. The part A asks participants to count from 1-25, while part B asks participants to alternate between letters and numbers. The less amount of time required to complete the task equates to better cognition.
One day
Remote assessment of cognition using the COWA Test
Time Frame: One day
Assess cognition remotely through a Zoom session by using the Controlled Oral Word Association (COWA) Test, a brief cognitive test of oral fluency and executive function. The COWAT has two components, the first asks the participants to say as many words as possible that begin with a given letter (F, A, or S) within the one-minute time frame. The second trial asks the same task but instead of letters, the participant is asked to produce as many animals as possible within the provided time frame. More words produced are indicative of better cognitive function.
One day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of presence of CRCI symptoms (Neuro-Qol)
Time Frame: One day
Assess the presence of cancer-related cognitive impairment (CRCI) symptoms using the Neuro-QoL Cognitive Function Test, a self-report measurement of cognitive function. Higher scores indicate better cognitive functioning with a range from 8 - 40 for the raw score and a T-score range from 17.3 - 64.2.
One day
Assessment of presence of CRCI symptoms (FACT-Cog)
Time Frame: One day
Assess presence of cancer-related cognitive impairment (CRCI) symptoms using the Functional Assessment of Cancer Therapy - Cognition (FACT-Cog), a self-report measurement of cognitive function. Higher scores indicate better cognition with a range from 0 - 80.
One day
Assessment of Diet Quality Measures
Time Frame: One day
Assess diet quality measures from an electronic food frequency questionnaire.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Tonya S Orchard, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 17, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-22367

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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