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

Phase 3
Open (Enrolling)
Gastric Cancer, Colorectal Cancer, Chemotherapy

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Trial Information

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

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Outcome Measure:

Serum level of proalbumin

Outcome Time Frame:

The starting and ending day of the experiment for a certain subject (day1 and day21)

Safety Issue:


Principal Investigator

Huilian Zhu, MD

Investigator Role:

Study Director

Investigator Affiliation:

School of public health, Sun Yat-sen University


China: Ethics Committee

Study ID:




Start Date:

December 2009

Completion Date:

January 2012

Related Keywords:

  • Gastric Cancer
  • Colorectal Cancer
  • Chemotherapy
  • gastric cancer
  • colorectal cancer
  • chemotherapy
  • eicosapentaenoic acid
  • enteral nutrition
  • Colorectal Neoplasms
  • Stomach Neoplasms