drugset / Trial / NCT01048463
Effect of Enteral Nutrition Rich in Eicosapentaenoic Acid (EPA) on Patients Receiving Chemotherapy for GI Tumor
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2009-12
- Primary completion
- 2011-12
- Completion
- 2012-01
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EPA | Unknown | 3 g | — |
| Subject | EPA | Unknown | 6 g | — |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | — |
| Background | Oxaliplatin | Small molecule | 135 mg/m2 | — |