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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

Qualifiers

Newly diagnosed stage I-III breast cancer.

Treatment-naïve; no neoadjuvant therapy planned.

Surgery scheduled at Moffitt in 1-2 months.

Post-menopausal.

Disqualifiers

Stage IV/metastatic disease.

Prior cancer.

Surgery scheduled sooner than 4-5 weeks.

NCI FVS ≥5 servings/day.

Trial design

Treatments tested in this trial

  • Mediterranean Diet

Treatment groups

20 Participants
are divided into 1 treatment group