PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mediterranean Diet.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study
Overview
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.
Interventions
- Other Mediterranean Diet
A two-week cyclic menu (14 unique days of meals repeated) approach will be used for the Mediterranean diet intervention. Participants will be provided with 3 meals a day and receive daily snacks to consume.
Primary outcome measures
- Feasibility of Enrollment [Time frame: Up to 1 year]
- Retention [Time frame: 8 weeks post-surgery]
- Adherence [Time frame: At 4 weeks.]
- Acceptability [Time frame: 8 weeks post-surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT07638150 · MCC-24066