Clinical trial · Interventional
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mediterranean Diet | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mediterranean Diet
- description
- Participants receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan.
- interventionNames
- Other: Mediterranean Diet
Primary outcomes (4)
- measure
- Feasibility of Enrollment
- timeFrame
- Up to 1 year
- description
- Percentage of eligible participants who enroll.
- measure
- Retention
- timeFrame
- 8 weeks post-surgery
- description
- Percentage of enrolled participants will complete assessments at both timepoints
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available