Clinical trial · Interventional
Efficacy and Safety of a PN Regimen Containing n-3 Fatty Acid in Patients Considered After GI Surgery
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.
NCT00798447CI-TRIAL-00004977completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Evaluation of the impact of peri- and post-operative parenteral nutrition enriched with n-3 PUFA on post-operative inflammatory processes.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GI Cancer | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lipofundin MCT | Drug | — | UNRESOLVED |
| MLF 541 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- lipid emulsion with n-3 FA
- interventionNames
- Drug: MLF 541
- type
- ACTIVE_COMPARATOR
- label
- lipid emulsion without n-3 FA
- interventionNames
- Drug: Lipofundin MCT
Primary outcomes (1)
- measure
- reduction of pro inflammatory activity
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 µmol/L) * Patients with severe liver dysfunction with bilirubin \>2.5 mg/dL (\> 43 µmol/L) * Lipid disorders, in particular fasting serum triglycerides \> 250 mg/dL (\>2.85 mmol/L),
References
Publications (1)
- DERIVEDMa CJ, Wu JM, Tsai HL, Huang CW, Lu CY, Sun LC, Shih YL, Chen CW, Chuang JF, Wu MH, Wang MY, Lin MT, Wang JY. Prospective double-blind randomized study on the efficacy and safety of an n-3 fatty acid enriched intravenous fat emulsion in postsurgical gastric and colorectal cancer patients. Nutr J. 2015 Jan 21;14:9. doi: 10.1186/1475-2891-14-9. PMID 25609264