Clinical Trial 24066

• Overview

  Study Title:

  PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A pilot, feasibility study

  Summary:

  This study will evaluate the feasibility and acceptability of a Mediterranean diet-based feeding intervention as nutritional prehabilitation for newly diagnosed, treatment-naïve breast cancer patients prior to surgery.

  Objective:

  Aim 1: Evaluate the feasibility and acceptability of a Mediterranean diet-focused feeding intervention as prehabilitation for newly diagnosed breast cancer patients prior to their surgery. Aim 2: Examine the impacts of nutritional prehabilitation on clinical markers, including body composition, metabolic parameters, inflammation, and the gut microbiome. Aim 3: Assess the impact of a nutritional prehabilitation intervention on patient-reported psychological outcomes (mental health, quality of life, satisfaction), as well as clinician-reported outcomes (post-operative complications, length of stay, recovery) in order to evaluate overall therapeutic effectiveness and patient/clinician satisfaction.

• Inclusion Criteria

  • (1) are newly diagnosed with stage 1-3 breast cancer;
  • (2) are treatment naïve and will not undergo neoadjuvant therapy prior to surgery;
  • (3) have an upcoming initial surgery scheduled at Moffitt Cancer Center in 1-2 months;
  • (4) are post-menopausal;
  • (5) have a measured BMI of 28-35kg/m2;
  • (6) typically do not adhere to a Mediterranean or plant-based dietary regimen (NCI FVS score > (7) and are willing to consume only the provided meals for the study time period.
  • Participants must also complete a structured food allergy and sensitivity assessment during screening. Documented allergies will be reviewed by the study dietitian prior to enrollment confirmation.
  • If diagnosis has been rendered elsewhere and patient was referred to Moffitt Cancer Center for surgery, we will ask participants the location of diagnosis and will obtain relevant validation (e.g., path reports, MD’s diagnostic note, ICD-9 code) with appropriate participant release of information documentation.
  • Study participation will not delay surgery. Surgery scheduling remains entirely under the discretion of the surgical team and will not be modified for research purposes. Patients whose surgery is scheduled sooner than the 4-week intervention window will be excluded.

• Exclusion Criteria

  • (1) have stage 4 or metastatic cancer;
  • (2) have previously had cancer;
  • (3) are not able to complete 4 weeks of a nutritional intervention due to surgery schedule scheduled sooner than 4-5 weeks
  • (4) NCI FVS score ≥ 5 servings/day (meaning 5 or more servings of fruits and vegetables daily);
  • (5) are taking GLP1s for weight loss purposes
  • Additional diet-specific exclusion criteria include: Diagnosed Celiac Disease or gluten intolerance requiring strict gluten-free diet. Severe food allergies (e.g., nuts, fish, shellfish) that cannot be safely accommodated. Severe renal disease requiring protein restriction. Uncontrolled diabetes requiring highly individualized carbohydrate regulation. Any medically prescribed diet incompatible with study macronutrient targets (e.g., strict low sodium > For participants with mild food sensitivities or minor intolerances (e.g., lactose sensitivity), reasonable substitutions within the standardized menu framework may be made by the study dietitian while maintaining caloric and macronutrient targets.

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