Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum level of proalbumin | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Fang, MD | Contact | 86-0-13539951951 | fangshi2008@yahoo.com.cn | |
| Hanping Shi, MD, PhD | Contact | 86-0-13802741263 | shihp38@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Huilian Zhu, MD | Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11383684 | Background | 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. | |
| 19090549 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015118 | Eicosapentaenoic Acid |
| D005780 | Gelatin |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| Chemotherapy | Drug | Oxaliplatin 135mg/m2 d1，xeloda 1000mg/m2 d1-21. (XELOX) |
|
|
| 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) |
| CD distribution of T cells | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of different types of immunoglobulin | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of different types of cytokines | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of Cortisol | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of transferrin | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of ALT and AST | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of creatine and BUN | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of total triglyceride, total cholesterol, LDL, HDL | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Records of EPA intake | The whole experiment period |
| Records of chemotherapy-associated side effects | The whole experiment period |
| Serum level of albumin | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Serum level of CEA, CA125, CA199 | The starting and ending day of the experiment for a certain subject (day1 and day21) |
| Records of Nutriall intake | The whole experiment period |
| Records of food intake | The middle 3 days of the whole experiment period (day10, day11, day12) |
| 15365767 | 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. |
| 2071835 | 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. |
| 16327975 | 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. |
| 19318040 | 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. |
| 12454764 | 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. |
| 17021855 | 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. |
| 16351506 | 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. |
| 15899583 | 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. |
| 16796925 | 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. |
| 11221959 | 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. |
| 17043961 | 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. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008055 |
| Lipids |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013812 | Therapeutics |