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A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.


Phase 3
18 Years
80 Years
Not Enrolling
Both
GI Cancer

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Trial Information

A Prospective, Randomized, Double Blind Study to Compare the Efficacy and Safety of a n-3 Fatty Acid-containing Lipid Emulsion During Parenteral Nutrition in Patients Considered for Major Surgery for Gastric and Colorectal Cancer.


Inclusion Criteria:



- Patients considered for major surgery for gastric and colorectal cancer

- expected requirement for post operative PN or TPN of at least 7 days

- possibility of PN/TPN provision 1 day prior to surgery

- Age >18 years old and <80 years old

- Hemodynamically stable

- Written Informed consent

Exclusion Criteria:

- Participation in a clinical study with an investigational drug or an investigational
medical device within one month prior to the start of study

- Patients with sepsis, severe sepsis or septic shock

- Known or suspected drug abuse

- Intrahepatic cholestasis

- General contraindications for infusion therapy such as acute pulmonary edema,
hyperhydration and decompensated cardiac insufficiency

- Pregnancy (positive in urine) or lactation

- Autoimmune disease e.g. HIV

- Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients of
the investigational products

- Hemodynamic failure of any origin (hemorrhagic shock, myocardial infarction, cardiac
failure)

- Alterations of coagulation (thrombocytes <150000 /mm3), PT < 50%, PTT > 40 sec

- Ketoacidosis caused by Diabetes mellitus within 7 days prior to onset of study

- Renal insufficiency with serum creatinine > 1.4 mg/dL (>124 ┬Ámol/L)

- Patients with severe liver dysfunction with bilirubin >2.5 mg/dL (> 43 ┬Ámol/L)

- Lipid disorders, in particular fasting serum triglycerides > 250 mg/dL (>2.85
mmol/L),

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

reduction of pro inflammatory activity

Outcome Time Frame:

30 days

Safety Issue:

No

Authority:

Taiwan: Department of Health

Study ID:

HC-G-H-0603

NCT ID:

NCT00798447

Start Date:

November 2008

Completion Date:

October 2010

Related Keywords:

  • GI Cancer
  • post OP

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