NCT07638150尚未招募不适用
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME): A Pilot, Feasibility Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mediterranean Diet
Experimental
Participants receive all meals and snacks for 4 weeks, following a standardized Mediterranean diet meal plan.
干预措施: Mediterranean Diet (Other)
研究者
研究点 (1)
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