## Protocol Section
### Identification Module
**NCT ID:** NCT00292279

**Brief Title:** The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients

**Official Title:** The Impact of Omega-3 Fat Emulsion on Clinical Outcome of Post-Operative Cancer Patients: A Randomized, Double Blind, Controlled, Multi-Center Clinical Trial.

#### Organization Study ID Info
**ID:** HL20020004
#### Organization
**Class:** INDUSTRY
**Full Name:** Fresenius Kabi Sino-Swed Pharmaceutical Corp. Ltd
### Status Module
#### Completion Date
**Date:** 2004-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2008-05-14

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-05-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2003-11

**Type:** ACTUAL

#### Start Date
**Date:** 2002-06

**Status Verified Date:** 2008-05

#### Study First Post Date
**Date:** 2006-02-15
**Type:** ESTIMATED
**Study First Submit Date:** 2006-02-13
**Study First Submit QC Date:** 2006-02-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sino-Swed Pharmaceutical Corporation

#### Responsible Party

**Old Name Title:** TF Ye

**Old Organization:** Ethic Committee of Peking Union Medical College Hospital

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate clinical safety and effect of Omega-3 fat oil emulsion on outcome in post-operative cancer patients.

**Detailed Description:** As an essential component of parenteral nutrition, fat emulsion has been used more than 30 years. It provides energy and essential fatty acids. Commercial fatty emulsion products mostly come from soy bean. The omega 6 fatty acids make up with the major fatty acids of this fat emulsion, and lack of omega 3 fatty acids generally. The imbalance of these two types of fatty acids may impact with negative clinical outcomes.

There are lots of omega 3 fatty acids makes up with fish oil emulsion, especially with eicosapentaenoic acid (EPA) and Docosahexaenoic acid (DHA).Few clinical studies found its clinical efficacy in recently years. A commercial product of omega 3 fat emulsion by Fresenius-Kabi was registered in Europe at 1998. There is no any clinical trial in Asia to elaborate the efficacy of omega 3 fat emulsion, as well the lack of large scale clinical trial in the world.

Currently study is the first large scale, randomized, double blind and multi-center clinical trial to elaborate the impact of fish oil fat emulsion in Asia and Europe.

### Conditions Module

**Conditions:**

- Carcinoma Surgery

- Parenteral Nutrition

- Post-Operative Hospital Stay

**Keywords:**

- Impact of Omega 3 fatty acid on outcome

- Omega-3 fatty acid

- Carcinoma surgery

- Digestive System

- Parenteral Nutrition

- Fat Emulsions, Intravenous

- Clinical outcome

- SIRS

- Infectious complication

- Postoperative hospital stay

- Cost of postoperative period

- Post-operative nutritional cost & total treatment cost

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 206

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Omega-3 fish oil emulsion (Omegaven )

**Label:** A

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: long-chain triglyceride

**Label:** B

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- A

**Description:** Patients of the treatment group received 0.2 g fish oil (10% Omegaven, Fresenius Kabi, Bad Homburg, Germany) and 1.0 g soy bean oil per kg BW per day

**Name:** Omega-3 fish oil emulsion (Omegaven )

**Other Names:**

- Omegaven

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- B

**Description:** the control group received 1.2 g soy bean oil (Intralipid, Sino-Swed,Wuxi,China)

**Name:** long-chain triglyceride

**Other Names:**

- Intralipid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Infectious complication

**Time Frame:** POD+1 to POD+14

**Measure:** Systemic inflammatory response syndrome (SIRS)

**Time Frame:** POD+1 to POD +8

#### Secondary Outcomes

**Measure:** Post-operative hospitalization days

**Time Frame:** POD+1 to discharge

**Measure:** Post operative nutritional cost & total treatment cost

**Time Frame:** POD+1 to discharge

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Post-operative male and female cancer patients
* Require post operative parenteral nutrition support at least 7 days based on nutritional risk screening(BMI 20-25)
* Sign an informed consent

Exclusion Criteria:

* Diabetes Mellitus
* Abnormal fatty metabolism (TG\>200mg/dl or cholesterol\>240mg/dl )
* Renal dysfunction (Cr\>1.6mg/dl or BUN\>30mg/dl)
* Liver dysfunction (ALT\>60U/L or TBIL\>1.2mg/dl)
* Lienectomy
* Temperature\>37.5°C
* Undergoing hormone therapy
* Pregnancy

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** People's Hospital, Beijing University

**Zip:** 100044

**Location 2:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Friendship Hospital

**Zip:** 100050

**Location 3:**

**City:** Beijing

**Country:** China

**Facility:** Beijing Hospital

**Zip:** 100730

**Location 4:**

**City:** Beijing

**Country:** China

**Facility:** Peking Union Medical College Hospital

**Zip:** 100730

**Location 5:**

**City:** Beijing

**Country:** China

**Facility:** General Hospital Of PLA

**Zip:** 100853

#### Overall Officials

**Official 1:**

**Affiliation:** Peking Union Medical College Hospital

**Name:** Zhu-ming Jiang, FACS

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** (Abstract) ZM Jiang, XR Wang, JM Wei, Y. Wang, Y. Li, S Wang, DW Wilmore. The impact of i.v. fish oil emulsion on clinical outcome & immune functions of post-operative cancer patients: a randomized, double blind, controlled, multi-center clinical trial for 203 cases Clinical Nutrition(Abstract for ESPEN 2005)(Absract No. 181)

**Citation:** Jiang ZM, Wilmore DW, Wang XR, Wei JM, Zhang ZT, Gu ZY, Wang S, Han SM, Jiang H, Yu K. Randomized clinical trial of intravenous soybean oil alone versus soybean oil plus fish oil emulsion after gastrointestinal cancer surgery. Br J Surg. 2010 Jun;97(6):804-9. doi: 10.1002/bjs.6999.

**PMID:** 20473991

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

### Intervention Browse Module - Ancestors

- ID: D000005217

- Term: Fat Emulsions, Intravenous

- ID: D000057947

- Term: Parenteral Nutrition Solutions

- ID: D000019999

- Term: Pharmaceutical Solutions

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M8360

- Name: Fat Emulsions, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M223889

- Name: Soybean oil, phospholipid emulsion

- Relevance: HIGH

- As Found: Mimic

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M28934

- Name: Parenteral Nutrition Solutions

- Relevance: LOW

- As Found: Unknown

- ID: T415

- Name: Omega 3 Fatty Acid

- Relevance: LOW

- As Found: Unknown

- ID: T294

- Name: Soy Bean

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000545823

- Term: Soybean oil, phospholipid emulsion

### Misc Info Module

- Version Holder: 2024-05-24
