PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)

PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study

This single-arm pilot study evaluates the feasibility and acceptability of a 4-week Mediterranean diet-based feeding intervention as nutritional prehabilitation for newly diagnosed, treatment-naïve breast cancer patients prior to surgery. All meals are provided to participants. Secondary aims include assessing changes in body composition, metabolic biomarkers, inflammation, gut microbiome composition, patient-reported outcomes, and clinician-reported surgical recovery metrics.

Inclusion Criteria:

• Newly diagnosed stage I-III breast cancer.
• Treatment-naïve; no neoadjuvant therapy planned.
• Surgery scheduled at Moffitt in 1-2 months.
• Post-menopausal.
• BMI 28-35 kg/m².
• NCI Fruit & Vegetable Screener <5 servings/day.
• Willing to consume only study-provided meals.

Exclusion Criteria:

• Stage IV/metastatic disease.
• Prior cancer.
• Surgery scheduled sooner than 4-5 weeks.
• NCI FVS ≥5 servings/day.
• Celiac disease, severe food allergies, severe renal disease, uncontrolled diabetes, or medically prescribed incompatible diets.