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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07638150

Acronym

PRIME

Enrollment

Registered

2026-06-10

Start date

2026-09-01

Completion date

2027-04-01

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

OTHERMediterranean 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTAlissa Pena

Alissa.Pena@moffitt.org813-745-7710

PRINCIPAL_INVESTIGATORTiffany Carson, PhD, MPH

Moffitt Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026