About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Newly diagnosed stage I-III breast cancer.
Treatment-naïve; no neoadjuvant therapy planned.
Surgery scheduled at Moffitt in 1-2 months.
Post-menopausal.
Disqualifiers
Stage IV/metastatic disease.
Prior cancer.
Surgery scheduled sooner than 4-5 weeks.
NCI FVS ≥5 servings/day.
Trial design
Single group
Treatments tested in this trial
Mediterranean Diet
Other interventionA 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of Enrollment
Percentage of eligible participants who enroll.
Retention
Percentage of enrolled participants will complete assessments at both timepoints
Adherence
Percentage of participants who consume ≥70% of study meals.
Acceptability
Percentage of participants who rate overall satisfaction as "agree" and "strongly agree."
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: