Conditions: Parenteral Nutrition (No Primary Condition Studied)
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 16
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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.

Interventions: intervention 1: 15% CLINISOL - Sulfite-free (Amino Acid) Injection intervention 2: 15% CLINISOL - Sulfite-free (Amino Acid) Injection intervention 3: 15% CLINISOL - Sulfite-free (Amino Acid) Injection
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: