Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in Net Protein Synthesis
研究概览
简要总结
The purpose of this study is to determine the best rate of infusion of amino acids (15% CLINISOL - sulfite-free (Amino Acid) Injection) for nutrition in subjects with with stages II to IVB head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- •Have Stages II to IVB head and neck cancer receiving radiation and may also be receiving chemotherapy.
- •* Subjects are eligible for inclusion in the study regardless of primary Stages II to IVB head and neck cancer treatment modality (eg, surgery, chemotherapy).
- •Have voluntarily signed and dated a written informed consent form (ICF) after the nature of the study was explained to them.
- •Female subjects must be of non childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or;
- •Female subjects of childbearing potential must be using adequate contraception (practicing 1 of the following methods of birth control):
- •total abstinence from sexual intercourse (minimum of 1 complete menstrual cycle before study entry),
- •a vasectomized partner,
- •contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to study drug administration,
- •intrauterine device (IUD), or
- •double barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
- •Female subjects must have a negative serum or urinary pregnancy test result at screening (serum specimen must be obtained within 14 days prior to baseline).
排除标准
- •Had a loss of > 10% of body weight within the 3 month period prior to the study as noted in the subjects medical history chart.
- •Have renal disease as determined by an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m
- •Have a hemoglobin level of < 9 g/dl.
- •Have Stage 0, I, or IVC metastatic cancer.
- •Have diabetes.
- •Have any reason which, in the opinion of the Investigator, would prevent the subject from safely participating in the study.
- •Have, in the opinion of the Investigator, a dependence on alcohol.
- •Have, in the opinion of the Investigator, a dependence on illicit drugs.
研究组 & 干预措施
15% CLINISOL 0.04 g/kg/hr
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
干预措施: 15% CLINISOL - Sulfite-free (Amino Acid) Injection (Drug)
15% CLINISOL 0.08 g/kg/hr
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
干预措施: 15% CLINISOL - Sulfite-free (Amino Acid) Injection (Drug)
15% CLINISOL 0.13 g/kg/hr
15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.
干预措施: 15% CLINISOL - Sulfite-free (Amino Acid) Injection (Drug)
结局指标
主要结局
Change in Net Protein Synthesis
时间窗: One time at pre-clinisol infusion and one time at post-clinisol infusion
次要结局
- Plasma Concentration of Glucose(Nine times during each 7 hour visit)
- Insulin Sensitivity(Five times during each 7 hour visit)
- Serum Concentration of Insulin(Five times during each 7 hour visit)
- Plasma Stable Isotope Enrichment of Phenylalanine(Twelve times during each 7 hour visit)
- Plasma Stable Isotope Enrichment of Tyrosine(Twelve times during each 7 hour visit)
- Plasma Concentration of Alanine(Three times during each 7 hour visit)
- Plasma Concentration of Arginine(Three times during each 7 hour visit)
- Plasma Concentration of Glutamic Acid(Three times during each 7 hour visit)
- Plasma Concentration of Aspartic Acid(Three times during each 7 hour visit)
- Plasma Concentration of Glutamine(Three times during each 7 hour visit)
- Plasma Concentration of Glycine(Three times during each 7 hour visit)
- Plasma Concentration of Histidine(Three times during each 7 hour visit)
- Plasma Concentration of Isoleucine(Three times during each 7 hour visit)
- Plasma Concentration of Leucine(Three times during each 7 hour visit)
- Plasma Concentration of Lysine(Three times during each 7 hour visit)
- Plasma Concentration of Methionine(Three times during each 7 hour visit)
- Plasma Concentration of Ornithine(Three times during each 7 hour visit)
- Plasma Concentration of Phenylalanine(Three times during each 7 hour visit)
- Plasma Concentration of Proline(Three times during each 7 hour visit)
- Plasma Concentration of Serine(Three times during each 7 hour visit)
- Plasma Concentration of Taurine(Three times during each 7 hour visit)
- Plasma Concentration of Threonine(Three times during each 7 hour visit)
- Plasma Concentration of Tyrosine(Three times during each 7 hour visit)
- Plasma Concentration of Valine(Three times during each 7 hour visit)