The Effect of Chemotherapy on Fat Metabolism and Digestion and Function in Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Hepatic triglyceride synthesis
研究概览
简要总结
Following chemotherapy, breast cancer patients primarily gain fat mass and lose muscle mass. Both depletion of muscle and an increase of fat mass in breast cancer patients are related to short survival, and decreased skeletal muscle mass and function may result in fatigue and inactivity, which contributes to fat mass changes and can be responsible for chemo-toxicity and increased mortality. The purpose of this study is to provide detailed insight in chemotherapy related changes in lipid metabolism and gut digestion and absorption of fat in breast cancer patients compared to matched healthy controls. This will provide required information that is necessary to implement new strategies to develop optimal nutritional regimen in breast cancer patients. The hypothesis is that chemotherapy in breast cancer is related to altered gut function and absorption and to increases in fat synthesis that lead to fat accumulation. In addition, we will examine the effect of cancer, chemotherapy, and gender by comparing fat digestion/absorption and fat metabolism of the breast cancer before and after chemotherapy, to aged matched healthy female and male controls.
详细描述
This research study involves 5 visits for the breast cancer subjects and 3 visits for the healthy controls. The first visit includes the informed consent and a screening and the second and third visit for the study days before chemotherapy and the fourth and fifth visit for the study days after chemotherapy. For the first test day, 2 hours of the subjects time will be for urine and blood sample collection, and to ingest the deuterated water. Subjects are allowed to go home after and eat normally. On the second study day, subjects will arrive early that morning and a DXA scan will be performed first. For the duration of the study, subjects have to lie in the bed (except for bathroom privileges). They can watch tv or bring and use a book/tablet. The research nurse or study staff will be present in the human subject area to assist the subject if necessary. Subjects are not allowed to eat or drink during the second test day, except for the test drink (meal) and water. One IV catheter will be placed in a vein of the arm/hand for blood draws. The hand will be placed in a hot box during blood collection. Another IV catheter will be placed in the contra-lateral forearm for a primed and continuous infusion of 2H5-glycerol. Over the two day time period, a total of 100-120 ml of blood will be obtained over approximately 19 samples. Stable isotopes will be ingested on the first test day, added to the test drinks on the second test day after the second hour, and infused on the second day. On the second test day, subjects will fill out questionnaires and perform muscle function tests. After completion of the study, we will provide the subject with a meal.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Presence of fever within the last 3 days
- •Untreated metabolic diseases including hepatic or renal disorder
- •Presence of acute illness or metabolically unstable chronic illness
- •Use of nutritional supplements within 5 days of first test day
- •Any other condition according to the PI or nurse that would interfere with the study or safety of the patient
- •Failure to give informed consent
- •Possible) pregnancy
结局指标
主要结局
Hepatic triglyceride synthesis
时间窗: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
changes in hepatic triglyceride synthesis before and after a meal
Hepatic de novo lipogenesis
时间窗: Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion
changes in hepatic de novo lipogenesis before and after a meal
次要结局
- Adipose tissue triglyceride synthesis(pre and 4 hours post meal)
- Adipose tissue de novo lipogenesis(pre and 4 hours post meal)
- Insulin response to feeding(pre and up to 5 hours post meal)
- Physical activity questionnaire(1 day)
- Adipose tissue lipolysis - glycerol rate of appearance(Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion)
- Fat digestion and absorption(Pre meal ingestion and 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, and 300 min post meal ingestion)
- Skeletal muscle strength and endurance(1 day)
- Body composition(1 day)
研究者
Marielle PKJ Engelen, PhD
Ph.D.
Texas A&M University