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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Guanqing Sun, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01048463
First received: January 12, 2010
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Colorectal Cancer
Chemotherapy
Drug: Nutriall
Drug: LDEPA
Drug: Placebo
Drug: HDEPA
Drug: Chemotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Enteral Nutrition Rich in Eicosapentaenoic Acid in Patients Receiving Chemotherapy for Gastric Cancer or Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Serum level of proalbumin [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Weight in light clothing [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Height and BMI [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Fat ratio and fat mass [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • CD distribution of T cells [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of different types of immunoglobulin [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of different types of cytokines [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of Cortisol [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of transferrin [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of ALT and AST [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of creatine and BUN [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Records of EPA intake [ Time Frame: The whole experiment period ] [ Designated as safety issue: Yes ]
  • Records of chemotherapy-associated side effects [ Time Frame: The whole experiment period ] [ Designated as safety issue: Yes ]
  • Serum level of albumin [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Serum level of CEA, CA125, CA199 [ Time Frame: The starting and ending day of the experiment for a certain subject (day1 and day21) ] [ Designated as safety issue: Yes ]
  • Records of Nutriall intake [ Time Frame: The whole experiment period ] [ Designated as safety issue: Yes ]
  • Records of food intake [ Time Frame: The middle 3 days of the whole experiment period (day10, day11, day12) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: December 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Gelatin capsule
Drug: Chemotherapy
Oxaliplatin 135mg/m2 d1,xeloda 1000mg/m2 d1-21. (XELOX)
Other Name: 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 Name: Complete Enteral Nutrition Emulsion for cancer patients
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 Name: Eicosapentaenoic acid
Drug: Chemotherapy
Oxaliplatin 135mg/m2 d1,xeloda 1000mg/m2 d1-21. (XELOX)
Other Name: XELOX chemotherapy
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 Name: Complete Enteral Nutrition Emulsion for cancer patients
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 Name: Eicosapentaenoic acid
Drug: Chemotherapy
Oxaliplatin 135mg/m2 d1,xeloda 1000mg/m2 d1-21. (XELOX)
Other Name: XELOX chemotherapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048463

Contacts
Contact: Shi Fang, MD 86-0-13539951951 fangshi2008@yahoo.com.cn
Contact: Hanping Shi, MD, PhD 86-0-13802741263 shihp38@hotmail.com

Locations
China, Guangdong
First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Han-ping Shi, MD, PhD    86-0-13802741263    shihp38@hotmail.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Director: Huilian Zhu, MD School of public health, Sun Yat-sen University
  More Information

Publications:

Responsible Party: Guanqing Sun, Dr., Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01048463     History of Changes
Other Study ID Numbers: EPACT
Study First Received: January 12, 2010
Last Updated: October 4, 2011
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
gastric cancer
colorectal cancer
chemotherapy
eicosapentaenoic acid
enteral nutrition

Additional relevant MeSH terms:
Colorectal Neoplasms
Stomach Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 24, 2014