Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MIND Diet Intervention Group, General Health Curriculum (GHC) Group.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 45 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT) [Time frame: One day]
- Remote assessment of cognition using the WAIS-IV Digit Span [Time frame: One day]
- Remote assessment of cognition using the Oral Trail Making Test [Time frame: One day]
- Remote assessment of cognition using the COWA Test [Time frame: One day]
Secondary outcome measures (3)
- Assessment of presence of CRCI symptoms (Neuro-Qol) [Time frame: One day]
- Assessment of presence of CRCI symptoms (FACT-Cog) [Time frame: One day]
- Assessment of Diet Quality Measures [Time frame: One day]
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Ohio State University Comprehensive Cancer Center — Columbus
Identifiers
NCT: NCT05984888 · OSU-22367