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

September 14, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute

PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Steven Sutton, PhD
        • Sub-Investigator:
          • Sylvia Crowder, PhD
        • Principal Investigator:
          • Tiffany Carson, PhD, MPH
        • Sub-Investigator:
          • Vivian Doerr, PhD
        • Sub-Investigator:
          • Doratha Byrd, PhD
        • Sub-Investigator:
          • Melissa Mallory, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mediterranean Diet
Participants receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Enrollment
Time Frame: Up to 1 year
Percentage of eligible participants who enroll.
Up to 1 year
Retention
Time Frame: 8 weeks post-surgery
Percentage of enrolled participants will complete assessments at both timepoints
8 weeks post-surgery
Adherence
Time Frame: At 4 weeks.
Percentage of participants who consume ≥70% of study meals.
At 4 weeks.
Acceptability
Time Frame: 8 weeks post-surgery
Percentage of participants who rate overall satisfaction as "agree" and "strongly agree."
8 weeks post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Tiffany Carson, PhD, MPH, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-24066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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