ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
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
Qualifiers
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
Treatments tested in this trial
- Mediterranean Diet
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov