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Behavioral Intervention
MIND Diet Intervention for Breast Cancer (MIND-BC Trial)
N/A
Recruiting
Led By Tonya S Orchard, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Stage II-IV hormone receptor+, breast cancer diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one day
Awards & highlights
MIND-BC Trial Summary
This trial looks at how the MIND diet (high in anti-inflammatory nutrients, low in brain-unhealthy foods) may help reduce memory and brain function decline in women with breast cancer after chemotherapy.
Who is the study for?
This trial is for English-speaking, post-menopausal women with Stage II-IV hormone receptor-positive breast cancer. They must be about to start systemic therapies like chemotherapy within +/- 4 weeks and cannot have a history of cognitive impairments or conditions such as dementia or stroke. Women already following the MIND diet closely or those unable to consume its foods are excluded.Check my eligibility
What is being tested?
The study tests if the MIND Diet, rich in anti-inflammatory nutrients and low in unhealthy foods, can protect brain function during cancer treatment. Participants will either follow this special diet or receive general health education (GHC), randomly assigned to see which method better supports cognitive functions.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments due to new food types but are generally expected to be minimal compared to drug interventions.
MIND-BC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is hormone receptor positive and is stage II-IV.
MIND-BC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Remote Assessment of Cognition using the Hopkins Verbal Learning Test (HVLT)
Remote assessment of cognition using the COWA Test
Remote assessment of cognition using the Oral Trail Making Test
+1 moreSecondary outcome measures
Assessment of Diet Quality Measures
Assessment of presence of CRCI symptoms (FACT-Cog)
Assessment of presence of CRCI symptoms (Neuro-Qol)
MIND-BC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MIND-BC Intervention GroupExperimental Treatment1 Intervention
Individual, tailored, behaviorally based nutrition counseling provided by a Registered Dietitian Nutritionist (RDN) and dietetic interns.
Group II: General Health Curriculum (GHC) ControlActive Control1 Intervention
Sessions of non-diet related health topic education.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
838 Previous Clinical Trials
507,981 Total Patients Enrolled
9 Trials studying Breast Cancer
5,383 Patients Enrolled for Breast Cancer
Tonya S Orchard, PhDPrincipal InvestigatorOhio State University
2 Previous Clinical Trials
95 Total Patients Enrolled
2 Trials studying Breast Cancer
95 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is hormone receptor positive and is stage II-IV.I am on insulin therapy for my diabetes.My breast cancer is triple negative.I am unable to understand and agree to the study's procedures and risks.I am post-menopausal.You are not willing or able to eat more than two types of MIND diet foods.I have a history of conditions that could affect my thinking or memory.Your MIND diet score is higher than 8.I am about to start or have just started my first cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: MIND-BC Intervention Group
- Group 2: General Health Curriculum (GHC) Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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