Dosing Study of Amino Acids in Seriously Ill Patients

March 23, 2017 updated by: Baxter Healthcare Corporation

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in Net Protein Synthesis
Time Frame: One time at pre-clinisol infusion and one time at post-clinisol infusion
One time at pre-clinisol infusion and one time at post-clinisol infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Insulin Sensitivity
Time Frame: Five times during each 7 hour visit
Five times during each 7 hour visit
Plasma Concentration of Glucose
Time Frame: Nine times during each 7 hour visit
Nine times during each 7 hour visit
Serum Concentration of Insulin
Time Frame: Five times during each 7 hour visit
Five times during each 7 hour visit
Plasma Stable Isotope Enrichment of Phenylalanine
Time Frame: Twelve times during each 7 hour visit
Twelve times during each 7 hour visit
Plasma Stable Isotope Enrichment of Tyrosine
Time Frame: Twelve times during each 7 hour visit
Twelve times during each 7 hour visit
Plasma Concentration of Alanine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Arginine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Aspartic Acid
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Glutamic Acid
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Glutamine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Glycine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Histidine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Isoleucine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Leucine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Lysine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Methionine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Ornithine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Phenylalanine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Proline
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Serine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Taurine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Threonine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Tyrosine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit
Plasma Concentration of Valine
Time Frame: Three times during each 7 hour visit
Three times during each 7 hour visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-12-0012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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