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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04567459
• Other study ID #: 202000035A3
• Status: Recruiting
• Phase: N/A
• Start date: January 27, 2021
• Est. completion date: February 22, 2021

Study information

• Verified date: January 2021
• Source: Chang Gung Memorial Hospital
• Contact: Wan-Hsiang Hu, M.D.
• Phone: 886-975056227
• Email: gary.hu0805[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Premium Amino Acids
after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital,Kaohsiung	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Hanben Enterprise

Country where clinical trial is conducted

Taiwan, 

References & Publications (11)

André 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyère 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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). pii: E1099. doi: 10.3390/nu10081099. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

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