PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)
PRIME
1 other identifier
interventional
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Aug 2026
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
Study Completion
Last participant's last visit for all outcomes
April 1, 2027
June 10, 2026
June 1, 2026
8 months
June 1, 2026
June 4, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Feasibility of Enrollment
Percentage of eligible participants who enroll.
Up to 1 year
Retention
Percentage of enrolled participants will complete assessments at both timepoints
8 weeks post-surgery
Adherence
Percentage of participants who consume ≥70% of study meals.
At 4 weeks.
Acceptability
Percentage of participants who rate overall satisfaction as "agree" and "strongly agree."
8 weeks post-surgery
Study Arms (1)
Mediterranean Diet
EXPERIMENTALParticipants receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Moffitt Cancer Center
Tampa, Florida, 33612, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tiffany Carson, PhD, MPH
Moffitt Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2026
First Posted
June 10, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 10, 2026
Record last verified: 2026-06