Clinical trial NCT06582615: Food for Thought - a Nutrition Intervention for Women Undergoing Active Treatment for Triple Negative Breast Cancer
Official title: Food for Thought - Pilot Study of a MIND Diet Intervention in Women Undergoing Active Treatment for Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anatomic Stage II Breast Cancer AJCC V8
Anatomic Stage III Breast Cancer AJCC V8
Triple-Negative Breast Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Institute for Cancer Research
First posted: 2024-09-03
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design with optional cross-over of the control group to the treatment group after 6-month follow-up.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized clinical trial is to learn if a healthy eating pattern called the MIND eating plan can reduce cancer-related cognitive impairment (commonly called "chemobrain") and other symptoms commonly experienced by women with newly diagnosed stage II-III triple negative breast cancer as they go through chemotherapy. The symptoms that will be measured include changes in memory and mental function, fatigue, sleep quality, anxiety, and depression.

Researchers will compare measures from women in the 12-week MIND eating plan virtual intervention to a general health coaching (GHC) virtual intervention to see if the MIND eating plan helps reduce symptoms. Women will be contacted for follow-up measures 6 months after the 12-week interventions.

Women randomly assigned to the GHC at the beginning of the study will have the opportunity to complete the MIND intervention after the 6-month follow-up. All study sessions and measures are done remotely.

Participants will:

* Be randomized to MIND or GHC interventions
* Complete all study measures remotely (by online questionnaires, virtual visits and mail )
* Attend 8 virtual sessions of about 15-60 minutes each over 12 weeks
* Be sent some of the key foods in the MIND eating plan during the MIND intervention
* Be contacted for follow-up measures 6 months after interventions

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the efficacy of a remotely delivered, highly accessible, 3-month MIND diet intervention (MIND-Breast Cancer \[BC\]) versus (vs.) general health curriculum (GHC) control to reduce CRCI and associated neuropsychological symptoms in 60 racially and ethnically diverse women with clinical stage II-III TNBC.

II. Evaluate the sustainability of dietary changes and outcome measures 6-months post-intervention.

EXPLORATORY OBJECTIVE:

I. Explore underlying mechanisms of the MIND-BC diet on CRCI and effects of early versus later participation in the dietary intervention.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive MIND counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks and follow a personalized diet for 12 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up.

ARM II: Patients receive general health recommendations counseling sessions over 30-60 minutes weekly for 4 weeks then over 15 minutes biweekly for 4 sessions over 8 weeks. Patients also wear a Fitbit and undergo dried blood spot collection on study and during follow up. After 6 month follow-up, patients may receive the MIND counseling sessions as in Arm I.

After completion of study intervention, patients are followed up at 6 months.

Eligibility criteria: Inclusion Criteria:

* Age 40-65 years
* Female with newly diagnosed stage II-III triple negative breast cancer
* Within 3 weeks prior to starting neoadjuvant chemotherapy OR up to 6 months after starting neoadjuvant chemotherapy
* 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
* Current healthy eating pattern reflected by high MIND diet score (e.g. \&gt; 8)
* Unwilling/unable to eat \&gt; 2 types of MIND food (e.g. avoids \&gt; 2 categories or food groups such as leafy greens, olive oil and non-fried fish)
* Currently pregnant
* Unable to give informed consent

Primary outcomes:
measure: Changes in Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV) Digit Span score
timeFrame: Baseline up to 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Tonya Orchard, PhD
role: PRINCIPAL_INVESTIGATOR
References: