Dosing Study of Amino Acids in Seriously Ill Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Parenteral Nutrition (No Primary Condition Studied)
• Intervention / Treatment: Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences
  • Texas
    • College Station, Texas, United States, 77843-4253
      • Texas A&M University, Center for Translational Research in Aging & Longevity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
Experimental: 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.	Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
Experimental: 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.	Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 13, 2013
• First Posted (Estimate): August 15, 2013

Study Record Updates

• Last Update Posted (Actual): March 27, 2017
• Last Update Submitted That Met QC Criteria: March 23, 2017
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: CT-12-0012