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

Starting soon · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT07638150

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

20

Starts

2026-08-01

Expected to finish

2027-04-01

Last updated by the study team

2026-06-10

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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