Clinical trial NCT05984888: Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)
timeFrame: One day
measure: Remote assessment of cognition using the WAIS-IV Digit Span
timeFrame: One day
measure: Remote assessment of cognition using the Oral Trail Making Test
timeFrame: One day
measure: Remote assessment of cognition using the COWA Test
timeFrame: One day
Secondary outcomes:
measure: Assessment of presence of CRCI symptoms (Neuro-Qol)
timeFrame: One day
measure: Assessment of presence of CRCI symptoms (FACT-Cog)
timeFrame: One day
measure: Assessment of Diet Quality Measures
timeFrame: One day
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Tonya S Orchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: