The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study
NCT ID: NCT04567459
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-01-27
2021-02-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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control group: chemotherapy
No intervention
No interventions assigned to this group
experimental group: chemotherapy and nutrition support
Premium amino acids 1pc bid for 6 months
Premium Amino Acids
after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening
Interventions
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Premium Amino Acids
after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening
Eligibility Criteria
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Inclusion Criteria
* Radical operation for stage III and stage II with high risk colorectal cancer
* Agree to join the trial and sign the informed consent form
Exclusion Criteria
* Unstable vital sign
* Not suitable after evaluation by Principal Investigator
20 Years
ALL
No
Sponsors
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Hanben Enterprise
UNKNOWN
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Wan-Hsiang Hu
Attending physician
Locations
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Chang Gung Memorial Hospital,Kaohsiung
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Chiang CJ, Lo WC, Yang YW, You SL, Chen CJ, Lai MS. Incidence and survival of adult cancer patients in Taiwan, 2002-2012. J Formos Med Assoc. 2016 Dec;115(12):1076-1088. doi: 10.1016/j.jfma.2015.10.011. Epub 2016 Jan 16.
Andre T, Boni C, Navarro M, Tabernero J, Hickish T, Topham C, Bonetti A, Clingan P, Bridgewater J, Rivera F, de Gramont A. Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol. 2009 Jul 1;27(19):3109-16. doi: 10.1200/JCO.2008.20.6771. Epub 2009 May 18.
Casadaban L, Rauscher G, Aklilu M, Villenes D, Freels S, Maker AV. Adjuvant chemotherapy is associated with improved survival in patients with stage II colon cancer. Cancer. 2016 Nov 15;122(21):3277-3287. doi: 10.1002/cncr.30181. Epub 2016 Jul 15.
Gelibter AJ, Caponnetto S, Urbano F, Emiliani A, Scagnoli S, Sirgiovanni G, Napoli VM, Cortesi E. Adjuvant chemotherapy in resected colon cancer: When, how and how long? Surg Oncol. 2019 Sep;30:100-107. doi: 10.1016/j.suronc.2019.06.003. Epub 2019 Jul 2.
Jung HW, Kim JW, Kim JY, Kim SW, Yang HK, Lee JW, Lee KW, Kim DW, Kang SB, Kim KI, Kim CH, Kim JH. Effect of muscle mass on toxicity and survival in patients with colon cancer undergoing adjuvant chemotherapy. Support Care Cancer. 2015 Mar;23(3):687-94. doi: 10.1007/s00520-014-2418-6. Epub 2014 Aug 28.
Chen LK, Liu LK, Woo J, Assantachai P, Auyeung TW, Bahyah KS, Chou MY, Chen LY, Hsu PS, Krairit O, Lee JS, Lee WJ, Lee Y, Liang CK, Limpawattana P, Lin CS, Peng LN, Satake S, Suzuki T, Won CW, Wu CH, Wu SN, Zhang T, Zeng P, Akishita M, Arai H. Sarcopenia in Asia: consensus report of the Asian Working Group for Sarcopenia. J Am Med Dir Assoc. 2014 Feb;15(2):95-101. doi: 10.1016/j.jamda.2013.11.025.
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
Bano G, Trevisan C, Carraro S, Solmi M, Luchini C, Stubbs B, Manzato E, Sergi G, Veronese N. Inflammation and sarcopenia: A systematic review and meta-analysis. Maturitas. 2017 Feb;96:10-15. doi: 10.1016/j.maturitas.2016.11.006. Epub 2016 Nov 13.
Lin JX, Lin JP, Xie JW, Wang JB, Lu J, Chen QY, Cao LL, Lin M, Tu R, Zheng CH, Huang CM, Li P. Prognostic Value and Association of Sarcopenia and Systemic Inflammation for Patients with Gastric Cancer Following Radical Gastrectomy. Oncologist. 2019 Nov;24(11):e1091-e1101. doi: 10.1634/theoncologist.2018-0651. Epub 2019 Mar 25.
Tessier AJ, Chevalier S. An Update on Protein, Leucine, Omega-3 Fatty Acids, and Vitamin D in the Prevention and Treatment of Sarcopenia and Functional Decline. Nutrients. 2018 Aug 16;10(8):1099. doi: 10.3390/nu10081099.
Mazzuca F, Roberto M, Arrivi G, Sarfati E, Schipilliti FM, Crimini E, Botticelli A, Di Girolamo M, Muscaritoli M, Marchetti P. Clinical Impact of Highly Purified, Whey Proteins in Patients Affected With Colorectal Cancer Undergoing Chemotherapy: Preliminary Results of a Placebo-Controlled Study. Integr Cancer Ther. 2019 Jan-Dec;18:1534735419866920. doi: 10.1177/1534735419866920.
Other Identifiers
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202000035A3
Identifier Type: -
Identifier Source: org_study_id
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