Whole-Food, Plant-Based Nutrition Among Women With Metastatic Breast Cancer: A Pilot Study of Recruitment, Retention, and Preliminary Changes in Biomarkers and Symptoms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Retention
研究概览
简要总结
This research will examine the feasibility of conducting a strict whole-food, plant-based dietary intervention in women with stable metastatic breast cancer currently undergoing conventional treatments. In addition, this research will provide preliminary data on dietary intakes and the effect of plant-based nutrition on numerous outcomes reflecting cancer prognosis and overall health using advanced imaging, various blood biomarkers linked to cancer progression, and numerous symptom questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Women with a confirmed diagnosis of metastatic breast cancer with a stable treatment regimen, demonstrated by no changes in primary cancer therapy 6 weeks prior to consent and no anticipated changes in primary cancer therapy in the 4 weeks following consent.
- •Systemic therapy may consist of any conventional treatment including anti-hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have previously declined conventional cancer therapy are also eligible provided they meet all other eligibility criteria.
- •Expected to survive for at least 6 months.
- •Eligibility classification for enrollment into the study - T: any; N: any; M:
- •Any ER/PR/HER2 status is eligible.
- •Age > 18 years.
- •Must be willing to adopt a strict, whole-foods, plant-based diet.
- •Participant must be willing and able to comply with the protocol for the duration of the study including scheduled testing and weekly office visits.
- •Able to speak and read English fluently.
排除标准
- •Inability to tolerate a normal diet.
- •Current use of insulin or sulfonylureas.
- •Active malabsorption syndrome at time of consent (ie. Crohn's disease, major bowel resection leading to permanent malabsorption).
- •Current eating disorder.
- •Uncontrolled diarrhea.
- •Plant-based food allergies or intolerances.
- •Recent consumption (in the past 6 months) of a vegan diet.
- •GFR < 30 on 2 or more lab tests in the past 90 days.
- •Serum potassium > 5.3 on 2 or more lab tests in the past 90 days.
- •Major surgery within 2 months of starting study program.
- •Psychiatric disorder that prohibits giving informed consent.
- •Current smoking.
- •Current high risk alcohol use (> 7 drinks per week).
- •Current illicit substance use.
- •Current warfarin use.
结局指标
主要结局
Retention
时间窗: 8 weeks
Percentage of women who start the intervention who go on to complete 8-week testing
Recruitment
时间窗: 1 year
Percentage of women who are randomized in the study out of the all women approached.
Compliance
时间窗: 8 weeks
The percentage of daily calorie intake from "on-plan" food will be calculated for each participant.
次要结局
- Inflammatory Markers(8 weeks)
- EORTC QLQ-C30(8 weeks)
- Symptom Inventory(8 weeks)
- Blood Pressure(8 weeks)
- Metabolic Markers(8 weeks)
- Tumor Metabolic Activity as assessed by Positron Emission Tomography/ Computer Tomography (PET/CT)(8 weeks)
- Changes in nutrient intakes based on 3 day food diaries(8 weeks)
- FACT-B(8 weeks)
- Brief Fatigue Inventory (BFI)(8 weeks)
- Tumor Metabolic Activity(8 weeks)
- Circulating Tumor Cells(8 weeks)
- FACT-COG(8 weeks)
- Serum breast cancer biomarkers(8 weeks)
- Weight(8 weeks)
- Hormonal Levels(8 weeks)
- cell-free DNA(8 weeks)
研究者
Thomas M Campbell
Instructor of Clinical Family Medicine
University of Rochester