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临床试验/NCT01694602
NCT01694602已完成不适用

Non-Invasive Assessment of Skeletal Muscle Loss in Cancer Patients - Phase 2

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.

研究概览

简要总结

The overall aim of this research is to develop a non-invasive approach to evaluate the production of 3-methylhistidine (3MH)in cancer patients, as a potential means of determining which patients are at high risk for future development of cancer induced skeletal muscle atrophy.

Rationale: The approach is based on the hypothesis that after an oral dose of deuterated 3-methylhistidine (D-3MH), the slope of the terminal portion of the decay curve (> 12 hours post-dosing) for the tracer/tracee (D-3MH/3MH) in the free 3MH pool is proportional to the rate constant for myofibrillar protein degradation and can be determined from spot urine samples.

详细描述

The long-term objective of this research is to develop a non-invasive approach for assessment of de novo 3MH production in cancer patients early in the course of the disease as a way of assessing which patients are at high risk for future development of skeletal muscle atrophy. The approach is based on: 1) the known increase in de novo production of 3-methylhistidine (3MH) from muscle protein breakdown in said patients as a consequence of their unique disease-host interactions, and 2) earlier demonstration that de novo 3MH production can be measured in vivo using isotope dilution.

During this Phase-II project, we propose to conduct a statistically powerful prospective investigation to demonstrate that measurement of the slope of the terminal decay curve (rate constant) with our approach in newly diagnosed cancer patients predicts future development of muscle wasting. We expect the outcome of the combined Phase-I and Phase-II research to lead to the early identification of elevated muscle catabolism in at-risk patients so that medical intervention can prevent future muscle atrophy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) histological or cytological evidence of NSCLC without curative options;
  • (2) over 18 years of age;
  • (3) patient reported weight loss of ≤5% of usual body weight in the last 6 months;
  • (4) life expectancy of greater than 6 months based on the judgement of treating physician;
  • (5) serum creatinine ≤1.5 times the upper limit of normal; and
  • (6) willing and able to give informed consent.

排除标准

  • malabsorption, intractable vomiting or gastrointestinal obstruction
  • congestive heart failure
  • edema or ascites
  • liver function test results that will preclude administration of prescribed therapy
  • pregnant, nursing, or, if of child-bearing age, unwilling to use contraceptives

结局指标

主要结局

Determination of myofibrillar protein degradation rate constant and slope of terminal decay curve.

时间窗: Spot urine (multiple) collections between 12 to 17 hours of D-3MH ingestion.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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