PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study tests whether a 4-week Mediterranean-style meal plan before breast cancer surgery is practical and acceptable to patients. It is for people newly diagnosed with breast cancer who have not started treatment, and all meals are provided. The study also tracks changes in the body, gut bacteria, well-being, and recovery after surgery.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Newly diagnosed with stage I–III (1–3) breast cancer.
- Have not started cancer treatment and have no cancer treatment planned before surgery.
- Have surgery scheduled at Moffitt in 1–2 months.
- Have gone through menopause.
- Have a body mass index (BMI), a measure of weight compared with height, of 28–35.
- Eat fewer than 5 servings of fruits and vegetables a day, based on a screening survey.
- Are willing to eat only meals provided by the study.
Who can't join
- Have stage IV (4) breast cancer, which has spread to distant parts of the body.
- Have had cancer before.
- Have surgery scheduled sooner than 4–5 weeks.
- Eat 5 or more servings of fruits and vegetables a day, based on a screening survey.
- Have celiac disease (an illness triggered by gluten), severe food allergies, severe kidney disease, or diabetes that is not controlled.
- Follow a medically prescribed diet that does not fit the study meal plan.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
FL
- Moffitt Cancer Center · Tampa, FL 33612Tiffany Carson, PhD, MPH · Principal investigatorVivian Doerr, PhD · Sub-investigatorSylvia Crowder, PhD · Sub-investigatorDoratha Byrd, PhD · Sub-investigatorMore trials in Tampa