MIND Diet for Breast Cancer

(MIND-BC Trial)

Overseen By Crystal Bryant

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Schizophrenia, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether the MIND diet can help breast cancer survivors improve cognitive function, which cancer treatment can affect. Participants will either follow the MIND diet, known for its brain health benefits, or continue their usual diet. The trial aims to determine if the MIND diet can make a positive difference over a 12-week period, with additional follow-up. Individuals who have had stage I-III breast cancer, completed treatment 6 months to 3 years ago, and experience cognitive impairment related to their cancer may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could enhance cognitive health for breast cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the MIND diet is safe for breast cancer survivors?

Research has shown that the MIND diet is generally easy for most people to follow. Studies have found that those who adhere closely to the MIND diet often experience positive health benefits. In one study, 65% of participants reported good results. Importantly, no serious side effects have been reported from following this diet.

The MIND diet emphasizes foods that support brain health, such as leafy greens, berries, and nuts. Some individuals might notice minor digestive changes when starting the diet, but these are usually temporary and not harmful. Overall, the diet is considered safe for most people, including breast cancer survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MIND diet for breast cancer because it offers a fresh approach by focusing on dietary patterns rather than traditional medical treatments like chemotherapy, radiation, or hormone therapy. Unlike standard treatments, which can have significant side effects, the MIND diet emphasizes brain-healthy foods like berries and leafy greens, potentially enhancing overall well-being without harsh side effects. Additionally, this diet could empower patients by giving them an active role in their treatment through lifestyle changes, which is a shift from more passive, treatment-focused approaches.

What evidence suggests that the MIND diet might be an effective treatment for breast cancer-related cognitive impairment?

Research has shown that following the MIND diet may slow memory and thinking problems. Studies have found that this diet could help prevent these issues, particularly in women. Those who closely adhere to the MIND diet tend to experience better health outcomes. In this trial, participants in the MIND Diet Arm will follow the MIND diet, which studies have linked to improved brain function in postmenopausal breast cancer survivors. While not all studies show strong effects, most report positive results. This suggests that the MIND diet might effectively improve brain health in breast cancer survivors. ^{2 3 4 5 6}

Who Is on the Research Team?

Sylvia Crowder

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

The MIND-BC Study is for breast cancer survivors who have finished their adjuvant treatment between 6 months and 3 years ago, are experiencing chronic cognitive impairment, and have a low MIND diet score (less than 8), indicating a diet not optimal for brain health.

Inclusion Criteria

Able to consume foods orally

I am over 18 years old.

Report a MIND diet score < 10 (range 0 to 14, higher score equates to higher diet quality)

Exclusion Criteria

Not meeting all of the inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants follow the MIND diet with weekly check-ins with a diet coach

12 weeks

Weekly check-in sessions

Maintenance

Participants continue the MIND diet to evaluate longer-term effects

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• MIND Diet

Trial Overview This study tests the effects of the MIND diet on cognitive function in breast cancer survivors. It's an RCT with two phases: a 12-week intervention phase where participants follow the MIND diet, followed by a maintenance phase to observe long-term effects.

How Is the Trial Designed?

Group I: MIND Diet Arm Experimental Treatment 1 Intervention

Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The MIND diet arm will be asked to participate in weekly "check-in" sessions with a diet coach supervised by a registered dietitian. To evaluate the longer-term effects of the MIND diet as a part of lifestyle change, we will also conduct a 3-month follow-up assessment.

Group II: Usual Diet Arm Active Control 1 Intervention

Participants (N=200) will be randomized 1:1 to a 12-week intervention phase. The usual diet participants will be provided with weekly grocery gift cards to purchase foods that follow their "usual" diet. Usual diet participants will also conduct a 3-month follow-up assessment.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820920302536

Adherence to the MIND Diet and Risk of Breast Cancer In the fully adjusted model including body mass index, those with the greatest MIND diet scores had 50% lower chance of breast cancer (OR, 0.50; 95% CI, 0.34- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07018986

The MIND-BC Study: MIND Diet for Breast Cancer Cognition We will recruit breast cancer survivors reporting CRCI with a MIND diet score < 8, based on a previously devised 14-item diet questionnaire designed to detect ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-05451

MIND Dietary Intervention to Prevent Cognitive Changes in ... Data has shown that following the MIND diet pattern may slow the rate of cognitive decline. The MIND diet intervention may prevent cognitive changes in women ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12313734/

The association of the MIND diet and its components with ... This was a cross-sectional study of 30 post-menopausal breast cancer survivors within one year of completing chemotherapy; 21 had complete data ...

5. mdpi.com mdpi.com/2072-6643/17/16/2687

Associations of the MIND Diet with Human Health Outcomes Higher adherence to the MIND diet was mostly associated with favorable health outcomes (65%), while roughly one-third (33%) of studies found no statistically ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33183968/

Adherence to the MIND Diet and Risk of Breast Cancer Results: After adjustment for age and energy intake, women in the top tertile of the MIND diet score had 60% lower odds of breast cancer than women in the ...