Clinical trial NCT01923480: Dosing Study of Amino Acids in Seriously Ill Patients
Official title: Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Parenteral Nutrition (No Primary Condition Studied)
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2013-08-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Net Protein Synthesis
timeFrame: One time at pre-clinisol infusion and one time at post-clinisol infusion
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: Five times during each 7 hour visit
measure: Plasma Concentration of Glucose
timeFrame: Nine times during each 7 hour visit
measure: Serum Concentration of Insulin
timeFrame: Five times during each 7 hour visit
measure: Plasma Stable Isotope Enrichment of Phenylalanine
timeFrame: Twelve times during each 7 hour visit
measure: Plasma Stable Isotope Enrichment of Tyrosine
timeFrame: Twelve times during each 7 hour visit
measure: Plasma Concentration of Alanine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Arginine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Aspartic Acid
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Glutamic Acid
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Glutamine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Glycine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Histidine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Isoleucine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Leucine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Lysine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Methionine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Ornithine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Phenylalanine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Proline
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Serine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Taurine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Threonine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Tyrosine
timeFrame: Three times during each 7 hour visit
measure: Plasma Concentration of Valine
timeFrame: Three times during each 7 hour visit
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: College Station
country: United States
facility: Texas A&M University, Center for Translational Research in Aging & Longevity
state: Texas
Study officials:
References: