Parenteral Nutrition (No Primary Condition Studied) Clinical Trial
Official title:
Determination of the Optimal Infusion Rate of Amino Acids in Seriously Ill Patients
| Verified date | February 2016 |
| Source | Baxter Healthcare Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 16 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Texas A&M University, Center for Translational Research in Aging & Longevity | College Station | Texas |
| United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
| Lead Sponsor | Collaborator |
|---|---|
| Baxter Healthcare Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Net Protein Synthesis | One time at pre-clinisol infusion and one time at post-clinisol infusion | ||
| Secondary | Insulin Sensitivity | Five times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Glucose | Nine times during each 7 hour visit | ||
| Secondary | Serum Concentration of Insulin | Five times during each 7 hour visit | ||
| Secondary | Plasma Stable Isotope Enrichment of Phenylalanine | Twelve times during each 7 hour visit | ||
| Secondary | Plasma Stable Isotope Enrichment of Tyrosine | Twelve times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Alanine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Arginine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Aspartic Acid | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Glutamic Acid | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Glutamine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Glycine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Histidine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Isoleucine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Leucine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Lysine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Methionine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Ornithine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Phenylalanine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Proline | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Serine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Taurine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Threonine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Tyrosine | Three times during each 7 hour visit | ||
| Secondary | Plasma Concentration of Valine | Three times during each 7 hour visit |