PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME) (NCT07638150) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)
United States20 participantsStarted 2026-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility of Enrollment
Timeframe: Up to 1 year
2
Retention
Timeframe: 8 weeks post-surgery
3
Adherence
Timeframe: At 4 weeks.
4
Acceptability
Timeframe: 8 weeks post-surgery
Trial details
NCT IDNCT07638150
SponsorH. Lee Moffitt Cancer Center and Research Institute