Dosing Study of Amino Acids in Seriously Ill Patients

Baxter

Status and phase: Terminated; Phase 4

Conditions: Parenteral Nutrition (No Primary Condition Studied)

Treatments: Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01923480

CT-12-0012

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

15% CLINISOL 0.04 g/kg/hr

Experimental group

Description:

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.

Treatment:

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

15% CLINISOL 0.08 g/kg/hr

Experimental group

Description:

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.

Treatment:

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

15% CLINISOL 0.13 g/kg/hr

Experimental group

Description:

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.

Treatment:

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection

Drug: 15% CLINISOL - Sulfite-free (Amino Acid) Injection