Dosing Study of Amino Acids in Seriously Ill Patients

NCT ID: NCT01923480

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-12-31

Brief 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.

Conditions

Parenteral Nutrition (No Primary Condition Studied)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

15% CLINISOL 0.04 g/kg/hr

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

15% CLINISOL 0.08 g/kg/hr

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

15% CLINISOL 0.13 g/kg/hr

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

CT-12-0012

Identifier Type: -

Identifier Source: org_study_id