Dosing Study of Amino Acids in Seriously Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients

Conditions
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Parenteral Nutrition (No Primary Condition Studied)

Intervention / Treatment
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* Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
* Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
* Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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/1.73m2. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 15% CLINISOL 0.04 g/kg/hr<br>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. | Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection<br> <br> |
| Experimental: 15% CLINISOL 0.08 g/kg/hr<br>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. | Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection<br> <br> |
| Experimental: 15% CLINISOL 0.13 g/kg/hr<br>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. | Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Net Protein Synthesis |  | One time at pre-clinisol infusion and one time at post-clinisol infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin Sensitivity |  | Five times during each 7 hour visit | 
| Plasma Concentration of Glucose |  | Nine 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 Aspartic Acid |  | Three times during each 7 hour visit | 
| Plasma Concentration of Glutamic 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 |