Mediterranean Diet for Breast Cancer

(PRIME Trial)

AP
Overseen ByAlissa Pena
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a Mediterranean diet can improve recovery for individuals newly diagnosed with breast cancer who have not yet started treatment. Participants will consume only provided meals for four weeks before surgery to assess the diet's impact on body health, inflammation, and surgical recovery. It suits post-menopausal women with stage I-III breast cancer, a BMI between 28-35, and a diet of fewer than five servings of fruits and vegetables daily. As an unphased trial, this study offers a unique opportunity to contribute to understanding the potential benefits of dietary changes on cancer recovery.

What prior data suggests that the Mediterranean Diet is safe for breast cancer patients?

Research has shown that the Mediterranean diet is generally safe and easy to follow. This diet emphasizes fruits, vegetables, whole grains, and healthy fats like olive oil. Known for its heart-health benefits, it is often recommended for this reason.

Regarding safety, no major side effects are typically reported. Many people worldwide incorporate this diet into their daily lives. This trial is a pilot study, where researchers are examining how this diet specifically affects breast cancer patients. Since the study involves a diet rather than a new drug or treatment, the safety risks remain low.

Overall, the Mediterranean diet is considered safe for most people. However, consulting a doctor before making significant dietary changes is always wise, especially for those with health conditions like breast cancer.12345

Why are researchers excited about this trial?

The Mediterranean Diet is unique because it focuses on enhancing overall health through nutrition, rather than relying on traditional medical interventions like chemotherapy or hormone therapy for breast cancer. This diet is rich in fruits, vegetables, whole grains, and healthy fats, which are known for their anti-inflammatory and antioxidant properties. Researchers are excited about this approach because it offers a holistic, non-invasive way to potentially improve treatment outcomes and quality of life for breast cancer patients without the side effects often associated with conventional treatments.

What evidence suggests that the Mediterranean Diet might be an effective treatment for breast cancer?

Research has shown that the Mediterranean diet might help lower the risk of breast cancer. One study found that women who followed this diet had a 62% lower risk of developing serious breast cancer. Another long-term study demonstrated up to a 77% reduction in breast cancer risk for those who adhered to this eating pattern. The Mediterranean diet includes plenty of fruits, vegetables, olive oil, and whole grains. It might also enhance treatment effectiveness and reduce the likelihood of cancer recurrence. Overall, this diet is linked to numerous health benefits, making it a promising choice for those aiming to lower their breast cancer risk. Participants in this trial will receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan.678910

Who Is on the Research Team?

TC

Tiffany Carson, PhD, MPH

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for post-menopausal women with newly diagnosed stage I-III breast cancer who haven't started any treatment and are scheduled for surgery in 1-2 months. Participants must have a BMI between 28-35, eat less than 5 servings of fruits/vegetables daily, and be willing to eat only meals provided by the study.

Inclusion Criteria

I have been newly diagnosed with stage I-III breast cancer.
I have not received any cancer treatment and none is planned before the main treatment.
My surgery at Moffitt is scheduled within the next 1-2 months.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive a 4-week Mediterranean diet-based feeding intervention as nutritional prehabilitation

4 weeks
Weekly check-ins (virtual or in-person)

Surgery and Immediate Recovery

Participants undergo surgery and immediate post-surgical recovery is monitored

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of body composition, metabolic biomarkers, and patient-reported outcomes

8 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Mediterranean Diet

Trial Overview

The study tests if following a Mediterranean diet for four weeks before surgery is practical and acceptable for breast cancer patients. All participants receive prepared Mediterranean-style meals during this period.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mediterranean DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Citations

The Role of the Mediterranean Diet in Breast Cancer ... - PMC

The Mediterranean diet (MD) is associated with reduced breast-cancer risk and various health-related benefits in the general population, but its effect on ...

Mediterranean diet and risk of breast cancer: An umbrella ...

The results of this umbrella review suggest that adherence to a MedDiet pattern had a protective effect on the risk of breast cancer, especially for ...

Does a Mediterranean-Style Diet Reduce Cancer Risk?

... Mediterranean diet lowered their risk of breast cancer by as much as 77 percent. A long-term study of 120,852 men and women whose eating ...

Mediterranean diet and breast cancer: A narrative review

The mediterranean diet may reduce breast cancer mortality by improving treatment response and reducing recurrence risk. Its benefits extend ...

Evaluation of a 12-week Mediterranean diet-based ...

Outcomes evaluated included BMI, dietary adherence, fatigue, and menopausal symptoms. up to 96% of survivors experience some degree of weight gain post- ...

Breast Cancer Awareness Month

Since the first BCAM more than 40 years ago, breast cancer death rates in the U.S. have dropped by 44% , we can save lives.

Breast Cancer - NCI

Explore the links on this page to learn more about breast cancer prevention, screening, treatment, statistics, research, clinical trials, and more.

8.

bcsc-research.org

bcsc-research.org/

Breast Cancer Surveillance Consortium (BCSC)

GET DATA. Access one of the BCSC's publicly available datasets, learn about what's involved in requesting a custom dataset, and find summaries of key variables ...

Breast

Factors that appear to be implicated in decreasing the risk of breast cancer ... diet, exercise to decrease excess body fat, and breastfeeding.

Breast Cancer - RTAnswers.org

Breast cancer can often be cured, with about 80% of all patients with breast cancer living at least 10 years after their diagnosis.