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Trial Title:
Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
NCT ID:
NCT05984888
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
MIND Diet Intervention Group
Description:
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.
Arm group label:
MIND-BC Intervention Group
Intervention type:
Behavioral
Intervention name:
General Health Curriculum (GHC) Group
Description:
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.
Arm group label:
General Health Curriculum (GHC) Control
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
45 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Tonya S Orchard, PhD
Phone:
614-292-7241
Email:
orchard.6@osu.edu
Contact backup:
Last name:
Kellie R Weinhold, MS
Email:
weinhold.8@osu.edu
Contact backup:
Last name:
Tonya S Orchard, PhD
Start date:
October 26, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984888
http://cancer.osu.edu
