Dosing Study of Amino Acids in Seriously Ill Patients
Stopped early · Phase 4
Conditions studied: Parenteral Nutrition (No Primary Condition Studied)
In brief
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.
Key facts
- Study ID
- NCT01923480
- Run by
- Baxter Healthcare Corporation
- People needed
- 16
- Starts
- 2013-07-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2017-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
- Texas A&M University, Center for Translational Research in Aging & Longevity — College Station, Texas, United States
Full record on ClinicalTrials.gov
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