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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean Diet | Experimental | Participants receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean Diet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Enrollment | Percentage of eligible participants who enroll. | Up to 1 year |
| Retention | Percentage of enrolled participants will complete assessments at both timepoints | 8 weeks post-surgery |
| Adherence | Percentage of participants who consume ≥70% of study meals. | At 4 weeks. |
| Acceptability | Percentage of participants who rate overall satisfaction as "agree" and "strongly agree." | 8 weeks post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alissa Pena | Contact | 813-745-7710 | Alissa.Pena@moffitt.org |
| Name | Affiliation | Role |
|---|---|---|
| Tiffany Carson, PhD, MPH | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |