Feasibility Study of Ultrasound to Evaluate Muscle-Glycogen Content in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Glycogen Storage Assessment
研究概览
简要总结
This trial studies how well an ultrasound procedure (non-invasive MuscleSound technology) can be used to learn about levels of glycogen (a type of sugar) in cancer patients during inpatient rehabilitation. The ultrasound information will be processed to represent the energy storage in the muscle. The energy storage in the muscle may help future research to look for dietary plans that can help to increase energy storage, patient exercise tolerance, and functional improvement.
详细描述
PRIMARY OBJECTIVES:
I. Determine feasibility of using non-invasive MuscleSound technology to determine glycogen stores in cancer patients.
EXPLORATORY OBJECTIVES:
I. Determine the baseline glycogen storage in two different groups of cancer patients, who are undergoing inpatient rehabilitation: (1) those with cachexia; (2) those without cachexia.
II. Determine the rate of depletion of muscle-glycogen stores by calculating the "Fuel Rating" score (FRS) at baseline, after 10-min of exercise and then again after 20-min of exercise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are willing and able to give written informed consent and to comply with study procedures.
- •Patients with a biopsy-confirmed solid malignant neoplasm with at least one neurologically-intact lower extremity, who fit into one of the following groups:
- •Group 1: Patients with cachexia, defined by loss of > 5% of body weight over the preceding 6-months (in absence of simple starvation defined as intentional weight loss) or weight loss > 2% with BMI <
- •Group 2: Patients without cachexia, as defined above.
- •Patients who have a record of weight or BMI over preceding 6-months.
- •Patients must be receiving rehabilitation that includes exercise under the direction of a physical therapist.
排除标准
- •Non-English speaking patients.
- •Patient with neurological compromise of both lower extremities causing muscle atrophy.
- •Underlying unstable medical condition (i.e: cardiac, pulmonary, or hematological) or musculoskeletal injury, which in the opinion of the investigator, limits participation in exercise of the measured lower extremity.
- •Patients who are unable to understand or follow through with study instructions.
结局指标
主要结局
Glycogen Storage Assessment
时间窗: Within 30 minutes of consent
Muscle-glycogen status will be assessed using ultrasound and MuscleSound® technology which generates an average FRS (Fuel Rating Score)
次要结局
未报告次要终点