Dosing Study of Amino Acids in Seriously Ill Patients
Condition: Parenteral Nutrition (No Primary Condition Studied)
Intervention: 15% CLINISOL - Sulfite-free (Amino Acid) Injection; 15% CLINISOL - Sulfite-free (Amino Acid) Injection; 15% CLINISOL - Sulfite-free (Amino Acid) Injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.