- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01218841
Pure Fish Oil Parenteral Lipid Emulsion in Patients With Gastrointestinal Cancer
Clinical and Immunological Benefits of the Infusion of Pure Fish Oil Lipid Emulsion in Surgical Patients With Gastrointestinal Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fish oil lipid emulsion
Parenteral lipid emulsion composed by fish oil which is rich in the omega-3 polyunsaturated fatty acids eicosapentanoic and docosahexanoic.
|
0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.
Other Names:
|
Active Comparator: MCT/LCT lipid emulsion
Parenteral lipid emulsion containing 50% of medium-chain triglycerides and 50% of soybean oil
|
0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.
Other Names:
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dan L. Waitzberg, PhD, University of Sao Paulo, Faculty of Medicine
Publications and helpful links
General Publications
- de Miranda Torrinhas RS, Santana R, Garcia T, Cury-Boaventura MF, Sales MM, Curi R, Waitzberg DL. Parenteral fish oil as a pharmacological agent to modulate post-operative immune response: a randomized, double-blind, and controlled clinical trial in patients with gastrointestinal cancer. Clin Nutr. 2013 Aug;32(4):503-10. doi: 10.1016/j.clnu.2012.12.008. Epub 2012 Dec 22.
- Cury-Boaventura MF, Torrinhas RS, de Godoy AB, Curi R, Waitzberg DL. Human leukocyte death after a preoperative infusion of medium/long-chain triglyceride and fish oil parenteral emulsions: a randomized study in gastrointestinal cancer patients. JPEN J Parenter Enteral Nutr. 2012 Nov;36(6):677-84. doi: 10.1177/0148607111432759. Epub 2012 Jan 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAPPesq 310/04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Surgify Medical OyCompletedSurgery | Spine SurgeryFinland
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
Clinical Trials on Fish oil lipid emulsion
-
B. Braun Melsungen AGCompleted
-
Alexandra N. CareyCompletedHematopoietic Stem Cell TransplantationUnited States
-
Children's Mercy Hospital Kansas CityCompletedParenteral Nutrition-related HepatitisUnited States
-
Fresenius KabiWithdrawnMalnutrition | Pediatric ALL | Neurocognitive Deficit | Parenteral Nutrition Associated Liver Disease | Essential Fatty Acid Deficiency
-
Wake Forest University Health SciencesCompletedTotal Parenteral Nutrition-induced CholestasisUnited States
-
Kapiolani Medical Center For Women & ChildrenCompleted
-
Fresenius KabiNot yet recruitingMalnutrition | Pediatric ALL | Essential Fatty Acid Deficiency | Parenteral Nutrition Associated Liver Disease (PNALD)
-
University of NebraskaChildren's Hospital and Medical Center, Omaha, NebraskaApproved for marketingTotal Parenteral Nutrition-Induced CholestasisUnited States
-
University Hospitals, LeicesterB. Braun Melsungen AGCompletedColorectal Liver MetastasesUnited Kingdom
-
University Hospitals, LeicesterCompletedAssess Effect of Omega-3 Fish Oil in Patients With Severe Acute PancreatitisUnited Kingdom