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

NCT01048463 | Unknown Phase 3 DMC

• 1 other identifier: EPACT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; Colorectal Cancer; Chemotherapy

Keywords

gastric cancer; colorectal cancer; chemotherapy; eicosapentaenoic acid; enteral nutrition

Outcome Measures

Primary Outcomes (1)

• Serum level of proalbumin

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

Secondary Outcomes (19)

• Weight in light clothing

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

• Height and BMI

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

• mid upper arm circumference and triceps skinfold thickness

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

• Fat ratio and fat mass

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

• Fat-free mass, muscle mass and muscle function

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

Study Arms (3)

EN

PLACEBO COMPARATOR

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; Drug: Placebo; Drug: Chemotherapy

ENLDEPA

EXPERIMENTAL

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; Drug: LDEPA; Drug: Chemotherapy

ENHDPEA

EXPERIMENTAL

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; Drug: HDEPA; Drug: Chemotherapy

Interventions

Nutriall DRUG

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.

Also known as: Complete Enteral Nutrition Emulsion for cancer patients

EN; ENHDPEA; ENLDEPA

LDEPA DRUG

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.

Also known as: Eicosapentaenoic acid

ENLDEPA

Placebo DRUG

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.

Also known as: Gelatin capsule

EN

HDEPA DRUG

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.

Also known as: Eicosapentaenoic acid

ENHDPEA

Chemotherapy DRUG

Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX)

Also known as: XELOX chemotherapy

EN; ENHDPEA; ENLDEPA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (13)

• Barber MD, Fearon KC. Tolerance and incorporation of a high-dose eicosapentaenoic acid diester emulsion by patients with pancreatic cancer cachexia. Lipids. 2001 Apr;36(4):347-51. doi: 10.1007/s11745-001-0726-4.

  PMID: 11383684 BACKGROUND

• Bayram I, Erbey F, Celik N, Nelson JL, Tanyeli A. The use of a protein and energy dense eicosapentaenoic acid containing supplement for malignancy-related weight loss in children. Pediatr Blood Cancer. 2009 May;52(5):571-4. doi: 10.1002/pbc.21852.

  PMID: 19090549 BACKGROUND

• Calviello G, Di Nicuolo F, Serini S, Piccioni E, Boninsegna A, Maggiano N, Ranelletti FO, Palozza P. Docosahexaenoic acid enhances the susceptibility of human colorectal cancer cells to 5-fluorouracil. Cancer Chemother Pharmacol. 2005 Jan;55(1):12-20. doi: 10.1007/s00280-004-0846-6. Epub 2004 Sep 10.

  PMID: 15365767 BACKGROUND

• Crooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. doi: 10.1093/geronj/46.4.m139.

  PMID: 2071835 BACKGROUND

• Elia M, Van Bokhorst-de van der Schueren MA, Garvey J, Goedhart A, Lundholm K, Nitenberg G, Stratton RJ. Enteral (oral or tube administration) nutritional support and eicosapentaenoic acid in patients with cancer: a systematic review. Int J Oncol. 2006 Jan;28(1):5-23. doi: 10.3892/ijo.28.1.5.

  PMID: 16327975 BACKGROUND

• Gorjao R, Azevedo-Martins AK, Rodrigues HG, Abdulkader F, Arcisio-Miranda M, Procopio J, Curi R. Comparative effects of DHA and EPA on cell function. Pharmacol Ther. 2009 Apr;122(1):56-64. doi: 10.1016/j.pharmthera.2009.01.004. Epub 2009 Feb 12.

  PMID: 19318040 BACKGROUND

• Pratt VC, Watanabe S, Bruera E, Mackey J, Clandinin MT, Baracos VE, Field CJ. Plasma and neutrophil fatty acid composition in advanced cancer patients and response to fish oil supplementation. Br J Cancer. 2002 Dec 2;87(12):1370-8. doi: 10.1038/sj.bjc.6600659.

  PMID: 12454764 BACKGROUND

• Read JA, Beale PJ, Volker DH, Smith N, Childs A, Clarke SJ. Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial. Support Care Cancer. 2007 Mar;15(3):301-7. doi: 10.1007/s00520-006-0153-3. Epub 2006 Oct 5.

  PMID: 17021855 BACKGROUND

• Read JA, Crockett N, Volker DH, MacLennan P, Choy ST, Beale P, Clarke SJ. Nutritional assessment in cancer: comparing the Mini-Nutritional Assessment (MNA) with the scored Patient-Generated Subjective Global Assessment (PGSGA). Nutr Cancer. 2005;53(1):51-6. doi: 10.1207/s15327914nc5301_6.

  PMID: 16351506 BACKGROUND

• Russell ST, Tisdale MJ. Effect of eicosapentaenoic acid (EPA) on expression of a lipid mobilizing factor in adipose tissue in cancer cachexia. Prostaglandins Leukot Essent Fatty Acids. 2005 Jun;72(6):409-14. doi: 10.1016/j.plefa.2005.03.002.

  PMID: 15899583 BACKGROUND

• Wang ZD, Peng JS, Chen S, Huang ZM, Huang L. [Effects of perioperative enteral immunonutrition on nutritional status, immunity and inflammatory response of elderly patients]. Zhonghua Yi Xue Za Zhi. 2006 May 30;86(20):1410-3. Chinese.

  PMID: 16796925 BACKGROUND

• Yam D, Peled A, Shinitzky M. Suppression of tumor growth and metastasis by dietary fish oil combined with vitamins E and C and cisplatin. Cancer Chemother Pharmacol. 2001;47(1):34-40. doi: 10.1007/s002800000205.

  PMID: 11221959 BACKGROUND

• Zhong HJ, Ying JE, Ma SL. [Effect of Supportan on nutritional status and immune function of late-staged gastric cancer patients undergoing chemotherapy]. Zhonghua Wei Chang Wai Ke Za Zhi. 2006 Sep;9(5):405-8. Chinese.

  PMID: 17043961 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms

Interventions

Eicosapentaenoic Acid; Gelatin; Drug Therapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Scleroproteins; Proteins; Amino Acids, Peptides, and Proteins; Therapeutics

Study Officials

• Huilian Zhu, MD

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Shi Fang, MD

CONTACT

86-0-13539951951; fangshi2008@yahoo.com.cn

Hanping Shi, MD, PhD

CONTACT

86-0-13802741263; shihp38@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 13, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: October 6, 2011

Record last verified: 2011-10

Locations

CN (1)