NCT05984888

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-10-26
• Primary completion: 2027-06-01
• Completion: 2027-12-01
• First posted: 2023-08-09
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States