Dosing Study of Amino Acids in Seriously Ill Patients (NCT01923480) | Clinical Trial Compass
TerminatedPhase 4
Dosing Study of Amino Acids in Seriously Ill Patients
United States16 participantsStarted 2013-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 est…
What they're measuring
1
Change in Net Protein Synthesis
Timeframe: One time at pre-clinisol infusion and one time at post-clinisol infusion