Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer

NCT ID: NCT05984888

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MIND-BC Intervention Group

Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.

Group Type EXPERIMENTAL

MIND Diet Intervention Group

Intervention Type BEHAVIORAL

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.

General Health Curriculum (GHC) Control

Sessions of non-diet related health topic education.

Group Type ACTIVE_COMPARATOR

General Health Curriculum (GHC) Group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Tonya Orchard

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tonya S Orchard, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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The Ohio State University Comprehensive Cancer Center

Role: CONTACT

800-293-5066

Kellie R Weinhold, MS

Role: CONTACT

Facility Contacts

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Tonya S Orchard, PhD

Role: primary

614-292-7241

Kellie R Weinhold, MS

Role: backup

Related Links

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Other Identifiers

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OSU-22367

Identifier Type: -

Identifier Source: org_study_id

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