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

The Ohio State University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: General Health Curriculum (GHC) Group; Behavioral: MIND Diet Intervention Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05984888

OSU-22367

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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 of starting initial systemic therapies (e.g. chemotherapy, targeted therapies, endocrine therapy)
• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

MIND-BC Intervention Group

Experimental group

Description:

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

Treatment:

Behavioral: MIND Diet Intervention Group

General Health Curriculum (GHC) Control

Active Comparator group

Description:

Sessions of non-diet related health topic education.

Treatment:

Behavioral: General Health Curriculum (GHC) Group