A Randomized Controlled Trial of Behavioral Education and Nutrition Delivery in Women With Metastatic Breast and Endometrial Cancer. (The BEND-MBEC Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Mean Change in Dietary Adherence at 13 and 26 Weeks
研究概览
简要总结
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer.
详细描述
This is a randomized controlled trial of a whole food, plant-based (WFPB) dietary intervention among women with metastatic breast or endometrial cancer. It is designed to explore whether this dietary intervention is sustainable in this population for 26 weeks and whether improvements in quality of life and cardiometabolic health demonstrated in a previous study are sustained. If so, this study will gather information to know whether these benefits translate into reduced overall mortality and cancer markers when compared with a control group that is matched for time and attention but does not implement dietary change. The intervention consists of a whole food plant-based dietary program, group education and individual coaching/visits while the control group gets general wellness group education and individual visits while maintaining their usual diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Female sex (as assigned at birth), aged 18 years or older
- •A confirmed diagnosis of endometrial or metastatic breast cancer. All subtypes are eligible
- •Treating oncologist approval and expected survival of at least six months
- •Undergoing any systemic treatment including hormonal, cytotoxic, targeted monoclonal antibody or small molecule kinase inhibitors or any combination of the above. Women who have active cancer and have been recommended but declined systemic treatment are also eligible.
- •Willing to adopt a strict, whole-foods, plant-based diet
- •Willing and able to comply with the WFPB protocol for the duration of the study including scheduled testing, Zoom meetings, and office visits
- •Able to speak and read English fluently.
- •Women with plans for radiation therapy or surgery are also eligible provided that they meet all other eligibility criteria.
排除标准
- •BMI ≤ 20.0 kg/m2
- •Inability to tolerate a normal diet
- •Active malabsorption syndrome at time of consent, as determined by study physicians (i.e. Crohn's disease, bowel surgery)
- •Any food allergies or intolerances that would interfere with study compliance
- •Recent consumption (in the past six months) of a vegan diet
- •eGFR < 30 on ≥ two lab tests in the past six months
- •Serum potassium > 5.4 in the past six months
- •Current insulin or sulfonylurea use
- •Current warfarin use (non-vitamin K antagonist allowed)
- •High-risk alcohol use (>7 drinks/wk)
- •Illicit substance use (not including marijuana)
- •Cognitive impairment or psychiatric disorder impairing ability to give consent.
研究组 & 干预措施
Control
Regular Diet with Cancer-Related Wellness Education and Support
干预措施: Control (Other)
Whole Food, Plant-Based Diet with Behavioral Education and Support
Whole Food, Plant-Based Diet with Behavioral Education and Support
干预措施: Whole Food, Plant-Based Diet with Behavioral Education and Support (Other)
结局指标
主要结局
Mean Change in Dietary Adherence at 13 and 26 Weeks
时间窗: 13 weeks, 26 weeks
Dietary adherence is assessed by study personnel using pre-specified criteria. Participants are considered "adherent" if ≥80% of total calories are consumed from 'on-plan' foods. A single adherence score is calculated as the percentage of calories consumed from on-plan foods, averaged over the assessment period. Higher scores indicate greater adherence.
Mean Change in Participant Retention at 13 and 26 Weeks
时间窗: 13 weeks, 26 weeks
Retention is calculated as the percentage of consented participants who provide both baseline and post-intervention assessments. Higher percentages indicate better retention in the WFPB dietary intervention.
次要结局
- Mean Change in Cardiometabolic Marker (Blood Glucose) at 13 and 26 Weeks Description:(13 weeks, 26 weeks)
- Mean Change in Hormonal Marker (IGF1) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Hormonal Marker (sex hormones) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Cognitive Dysfunction (FACT-COG) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Disease-Specific Quality of Life - FACT-B at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Disease-Specific Quality of Life - FACT-En at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Cancer-Related Fatigue (BFI) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in General Symptoms (MDASI) at 13 and 26 Week(13 weeks, 26 weeks)
- Overall Survival at Close of Study(End of study (26 weeks))
- Mean Change in Cardiometabolic Marker (Weight) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Cardiometabolic Marker (Lipids) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Cardiometabolic Marker (Blood Pressure) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Cardiometabolic Marker (Insulin) at 13 and 26 Weeks(13 weeks, 26 weeks)
- Mean Change in Cardiometabolic Marker (Inflammation) at 13 and 26 Weeks(13 weeks, 26 weeks)
研究者
Thomas M Campbell
Assistant Professor (Part-Time) - Department of Family Medicine (SMD)
University of Rochester