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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07638150
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mediterranean Diet — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Mediterranean Diet
    Participants receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan.

Primary Outcome Measure

Feasibility of Enrollment [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Tiffany Carson, PhD, MPH (PRINCIPAL_INVESTIGATOR)
Vivian Doerr, PhD (SUB_INVESTIGATOR)
Sylvia Crowder, PhD (SUB_INVESTIGATOR)
Doratha Byrd, PhD (SUB_INVESTIGATOR)
Melissa Mallory, MD (SUB_INVESTIGATOR)
Steven Sutton, PhD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Moffitt Cancer Center· Tampa, FL

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