The Effect of Nutrition for the Colorectal Cancer Patients Receiving Chemotherapy-randomized Controlled Study

We use clinical trial to explore the effect of nutrition support in colorectal cancer patients receiving postoperative adjuvant chemotherapy.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Premium Amino Acids

Detailed Description

Colorectal cancer is the most common cancer in Taiwan. Side effects induced by postoperative adjuvant chemotherapy will affect nutrition status and may delay treatment and affect prognosis. Sarcopenia may be noted in some patients and increase the toxicities of chemotherapy. The studies of intervention include nutrition consultant and treatment like protein, fish oil or Vitamin D supplement. Premium amino acids include multiple amino acids and organic Selenium and have effect in inhibition of tumor proliferation according to colorectal cancer cell and animal experiments.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wan-Hsiang Hu, M.D.; Phone Number: 886-975056227; Email: gary.hu0805@gmail.com

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Recruiting
    • Chang Gung Memorial Hospital,Kaohsiung
    • Contact: Wan Hsiang Hu; Phone Number: 8008 +886-7-7317123; Email: gary.hu0805@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 20
• 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:

• Unable to receive chemotherapy
• Unstable vital sign
• Not suitable after evaluation by Principal Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group: chemotherapy; No intervention
Experimental: experimental group: chemotherapy and nutrition support; Premium amino acids 1pc bid for 6 months	Dietary supplement: Premium Amino Acids; after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of adverse event	Evaluation of adverse event(Grade 1-4) between control group and experimental group before every chemotherapy(total 12 times)	2 weeks after chemotherapy
1)Nutrition assessment	albumin level between two group before every chemotherapy(total 12 times)	2 weeks after chemotherapy
2)Nutrition assessment	pre-albumin level between two group before every chemotherapy(total 12 times)	2 weeks after chemotherapy
1)Sarcopenia assessment muscle power	1-1)Assessment with Grip strength(Kg)	At 1st cycle of chemotherapy (each cycle is 2 weeks).
1)Sarcopenia assessment muscle power	1-2)Assessment with Grip strength(Kg)	At 12th cycle of chemotherapy (each cycle is 2 weeks).
2)Sarcopenia assessment muscle power	2-1)Assessment with ASM/heigh2(Kg/m2)	At 1st cycle of chemotherapy (each cycle is 2 weeks).
2)Sarcopenia assessment muscle power	2-2)Assessment with ASM/heigh2(Kg/m2)	At 12st cycle of chemotherapy (each cycle is 2 weeks).
3)Sarcopenia assessment	3-1)Assessment with speed(m/s)	At 1st cycle of chemotherapy (each cycle is 2 weeks).
3)Sarcopenia assessment	3-2)Assessment with speed(m/s)	At 12th cycle of chemotherapy (each cycle is 2 weeks).
4)Sarcopenia assessment	4-1)Assessment with DXA(g/cm2)	At 1st cycle of chemotherapy (each cycle is 2 weeks).
4)Sarcopenia assessment	4-2)Assessment with DXA(g/cm2)	At 12th cycle of chemotherapy (each cycle is 2 weeks).
5)Sarcopenia assessment	5-1)Assessment with abdominal CT	At 6th cycle of chemotherapy (each cycle is 2 weeks).
5)Sarcopenia assessment	5-2)Assessment with abdominal CT	At 12th cycle of chemotherapy (each cycle is 2 weeks).

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Collaborators: Hanben Enterprise

Publications and helpful links

General Publications

• 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. Erratum In: Age Ageing. 2019 Jul 1;48(4):601.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 27, 2021
• Primary Completion (Anticipated): February 22, 2021
• Study Completion (Anticipated): February 22, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: colorectal cancer; Nutrition; Chemotherapy; Sarcopenia
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 202000035A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No