Trial Information
Clinical and Immunological Benefits of the Infusion of Pure Fish Oil Lipid Emulsion in Surgical Patients With Gastrointestinal Cancer.
Inclusion Criteria:
Elective surgical patients with confirmed (biopsy) gastrointestinal (colon or stomach)
cancer; 30-75 years old; venous assess to blood collections (40 mL) to receive parenteral
infusions of lipid emulsion; Karnofsky performance statuses of ≥60
Exclusion Criteria:
Intolerance or allergy to any ingredient in lipid emulsion; diagnosis of infectious,
inflammatory, immunologic or metabolic diseases; dementia;medicine intake that could
significantly modulate metabolism; implanted electromagnetic instruments.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Principal Investigator
Dan L. Waitzberg, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Sao Paulo, Faculty of Medicine
Authority:
Brazil: Ethics Committee
Study ID:
CAPPesq 310/04
NCT ID:
NCT01218841
Start Date:
November 2005
Completion Date:
November 2008
Related Keywords:
- Surgery
- Fish oil
- Omega-3 fatty acids
- Parenteral lipid emulsions
- Immune response
- Surgery
- Gastrointestinal Neoplasms