[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07638150":3,"trial-entities:NCT07638150":105,"trial-summary:NCT07638150":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":14,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":32,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":51,"std_ages":67,"locations":70,"central_contacts":95,"overall_officials":101,"references":103,"see_also_links":104},"NCT07638150","MCC-24066","PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)","PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study","NOT_YET_RECRUITING","2027-04","2026-06","2026-06-10","2026-08","H. Lee Moffitt Cancer Center and Research Institute","OTHER",false,"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.",null,[19],"Breast Cancer",[],"INTERVENTIONAL",[23],"NA",{"count":25,"type":26},20,"ESTIMATED",[28],{"type":14,"name":29,"description":30,"armGroupLabels":31},"Mediterranean Diet","A 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.",[29],[33,37,41,45],{"measure":34,"description":35,"timeFrame":36},"Feasibility of Enrollment","Percentage of eligible participants who enroll.","Up to 1 year",{"measure":38,"description":39,"timeFrame":40},"Retention","Percentage of enrolled participants will complete assessments at both timepoints","8 weeks post-surgery",{"measure":42,"description":43,"timeFrame":44},"Adherence","Percentage of participants who consume ≥70% of study meals.","At 4 weeks.",{"measure":46,"description":47,"timeFrame":40},"Acceptability","Percentage of participants who rate overall satisfaction as \"agree\" and \"strongly agree.\"",[],"FEMALE","18 Years",{"inclusion":52,"exclusion":60,"raw_text":66},[53,54,55,56,57,58,59],"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\u002Fm².","NCI Fruit \\& Vegetable Screener \\\u003C5 servings\u002Fday.","Willing to consume only study-provided meals.",[61,62,63,64,65],"Stage IV\u002Fmetastatic disease.","Prior cancer.","Surgery scheduled sooner than 4-5 weeks.","NCI FVS ≥5 servings\u002Fday.","Celiac disease, severe food allergies, severe renal disease, uncontrolled diabetes, or medically prescribed incompatible diets.","Inclusion Criteria:\n\n* Newly diagnosed stage I-III breast cancer.\n* Treatment-naïve; no neoadjuvant therapy planned.\n* Surgery scheduled at Moffitt in 1-2 months.\n* Post-menopausal.\n* BMI 28-35 kg\u002Fm².\n* NCI Fruit \\& Vegetable Screener \\\u003C5 servings\u002Fday.\n* Willing to consume only study-provided meals.\n\nExclusion Criteria:\n\n* Stage IV\u002Fmetastatic disease.\n* Prior cancer.\n* Surgery scheduled sooner than 4-5 weeks.\n* NCI FVS ≥5 servings\u002Fday.\n* Celiac disease, severe food allergies, severe renal disease, uncontrolled diabetes, or medically prescribed incompatible diets.",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":92},"Moffitt Cancer Center","Tampa","Florida","33612","United States",[78,81,84,86,88,90],{"name":79,"role":80},"Tiffany Carson, PhD, MPH","PRINCIPAL_INVESTIGATOR",{"name":82,"role":83},"Vivian Doerr, PhD","SUB_INVESTIGATOR",{"name":85,"role":83},"Sylvia Crowder, PhD",{"name":87,"role":83},"Doratha Byrd, PhD",{"name":89,"role":83},"Melissa Mallory, MD",{"name":91,"role":83},"Steven Sutton, PhD",{"lat":93,"lon":94},27.94752,-82.45843,[96],{"name":97,"role":98,"phone":99,"email":100},"Alissa Pena","CONTACT","813-745-7710","Alissa.Pena@moffitt.org",[102],{"name":79,"affiliation":72,"role":80},[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]