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NCT Number: NCT07638150

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location contact

Doratha Byrd, PhD

SUB_INVESTIGATOR

Melissa Mallory, MD

SUB_INVESTIGATOR

Steven Sutton, PhD

SUB_INVESTIGATOR

Sylvia Crowder, PhD

SUB_INVESTIGATOR

Tiffany Carson, PhD, MPH

PRINCIPAL_INVESTIGATOR

Vivian Doerr, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Enrollment

    Time frame: Up to 1 year

    Percentage of eligible participants who enroll.

  2. Retention

    Time frame: 8 weeks post-surgery

    Percentage of enrolled participants will complete assessments at both timepoints

  3. Adherence

    Time frame: At 4 weeks.

    Percentage of participants who consume ≥70% of study meals.

  4. Acceptability

    Time frame: 8 weeks post-surgery

    Percentage of participants who rate overall satisfaction as "agree" and "strongly agree."

Study contacts

Contact information is provided by the study sponsor or research team.

Alissa Pena

CONTACT

[email protected]

813-745-7710

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Acronym: PRIME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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