Effect of Enteral Nutrition Rich in Eicosapentaenoic Acid (EPA) on Patients Receiving Chemotherapy for GI Tumor

October 4, 2011 updated by: Guanqing Sun, Sun Yat-sen University

Phase 3 Study of Enteral Nutrition Rich in Eicosapentaenoic Acid in Patients Receiving Chemotherapy for Gastric Cancer or Colorectal Cancer

Malnutrition is frequently seen in patients on chemotherapy suffering from gastric/colorectal cancer and may worsen the outcome. EPA, a sort of ω-3 PUFA, can modulate immune system. EPA also antagonizes metabolic and inflammatory changes induced by the tumor. This study is to test whether EPA, in combination with enteral nutrition, can improve nutritional/immunologic status, quality of life, and reduce chemotherapy related side effects of these patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy is indispensible for patients suffering from advanced gastric or colorectal cancer, and also the main therapy for those with end-stage tumor. However, incidence of malnutrition during chemotherapy was reported as high as 60%. The mechanisms include anatomy modification of digestive tract, side effects of chemotherapy such as anorexia, nausea, vomiting, and inflammatory factors generated or induced by the tumor. Malnutrition may lead to discontinuation of the therapy, compromise of the anti-cancer effect, increase of toxicity and mortality. 20%-40% of patients with end-stage tumor ultimately died from malnutrition.

EPA (Eicosapentaenoic acid, molecular formula C20H30O2) belongs to ω-3 polyunsaturated fatty acid (ω-3 PUFA). EPA is one of the main constituent of fish oil. EPA decreases LPS-stimulated macrophage production of TNF-α, IL-1β, IL-6, and human B lymphocytes production of IL-10, TNF-α, IFN-γ. EPA can suppress cancer induced lipolysis, and enhanced the inhibitory effect of 5-Fu over cancer cell proliferation. However, cancer patients are always lack of EPA.

Nutriall is a sort of non-elemental diet. The kind of powder is produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE. For this enteral nutrition preparation, there have been evidences of protective effects on nutritional status during chemotherapy on lung cancer. However, this kind of preparation does not contain EPA.

Up to date, there has been no RCT which testified whether therapeutic dosage of EPA plus enteral nutrition has combined effects on patients receiving chemotherapy. The investigators choose nutriall as basic nutritional support agent during chemotherapy, and give patients different dosage of EPA. Nutritional and immunologic status, quality of life and side effects of chemotherapy are recorded to evaluate whether EPA can improve outcome of these patients. Through this study the investigators may also optimize the dose of EPA for patients receiving chemotherapy on gastric/colorectal cancer.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • First Affiliated Hospital, Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The cases have undergone radical excision on gastric cancer or colorectal cancer.
  • Without contraindication for chemotherapy.
  • Eligible for postoperative adjuvant XELOX chemotherapy.
  • Capable of taking in food or drug orally.
  • Without severe absorption dysfunction
  • Able and willing to give written, informed consent

Exclusion Criteria:

  • Comorbidities: diseases of hematology or immunology system; hepatic or renal dysfunction; metabolic diseases.
  • BMI>35kg/m2
  • Life expectancy≤3mo
  • The chemotherapy treatment is palliative.
  • The patient has received radiotherapy or neoadjuvant chemotherapy prior to the operation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: EN
The subjects take in 150g of Nutriall per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d. During the test period patients are treated with the first course of XELOX.
Drug: Nutriall
The subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d.
Other Names:
  • Complete Enteral Nutrition Emulsion for cancer patients
Drug: Placebo
The subjects take in 24 pils of gelatin capsule (each contains 0.25g of olive oil, provided by nutritional department of our institute) per day. The treatment lasts for 21d.
Other Names:
  • Gelatin capsule
Drug: Chemotherapy
Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX)
Other Names:
  • XELOX chemotherapy
Experimental: ENLDEPA
The subjects take in the same dose of Nutriall for the same duration as those in EN group. In addition, they take in 3 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
Drug: Nutriall
The subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d.
Other Names:
  • Complete Enteral Nutrition Emulsion for cancer patients
Drug: Chemotherapy
Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX)
Other Names:
  • XELOX chemotherapy
Drug: LDEPA
The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.125g of EPA and 0.125g of olive oil. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
Other Names:
  • Eicosapentaenoic acid
Experimental: ENHDPEA
The subjects take in the same dose of supportan for the same duration as those in EN group. In addition, they take in 6 grams of EPA per day during the 21 days of treatment. The patients are treated with the first course of XELOX.
Drug: Nutriall
The subjects take in 150g of Nutriall (Produced by Guangdong Academy of Agriculture Science. Every 50 grams of nutriall contains 9.3mg of VitC and 0.8mg of VitE) per day. Oral administration of the liquid is divided into 3 times per day. The treatment lasts for 21d.
Other Names:
  • Complete Enteral Nutrition Emulsion for cancer patients
Drug: Chemotherapy
Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX)
Other Names:
  • XELOX chemotherapy
Drug: HDEPA
The subjects take in 24 pils of EPA capsule per day. The medium is gelatine. Each capsule contains 0.25g of EPA. The capsules are provided by nutritional department of our institute). The treatment lasts for 21d.
Other Names:
  • Eicosapentaenoic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum level of proalbumin
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight in light clothing
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Height and BMI
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
mid upper arm circumference and triceps skinfold thickness
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat ratio and fat mass
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Fat-free mass, muscle mass and muscle function
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
CD distribution of T cells
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of immunoglobulin
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of different types of cytokines
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of Cortisol
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of transferrin
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of ALT and AST
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of creatine and BUN
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of total triglyceride, total cholesterol, LDL, HDL
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of EPA intake
Time Frame: The whole experiment period
The whole experiment period
Records of chemotherapy-associated side effects
Time Frame: The whole experiment period
The whole experiment period
Serum level of albumin
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Serum level of CEA, CA125, CA199
Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21)
The starting and ending day of the experiment for a certain subject (day1 and day21)
Records of Nutriall intake
Time Frame: The whole experiment period
The whole experiment period
Records of food intake
Time Frame: The middle 3 days of the whole experiment period (day10, day11, day12)
The middle 3 days of the whole experiment period (day10, day11, day12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Huilian Zhu, MD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 12, 2010

First Posted (Estimate)

January 13, 2010

Study Record Updates

Last Update Posted (Estimate)

October 6, 2011

Last Update Submitted That Met QC Criteria

October 4, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPACT

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.

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