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

NCT ID: NCT04567459

Last Updated: 2021-01-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-27

Study Completion Date

2021-02-22

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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control group: chemotherapy

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

experimental group: chemotherapy and nutrition support

Premium amino acids 1pc bid for 6 months

Group Type EXPERIMENTAL

Premium Amino Acids

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanben Enterprise

UNKNOWN

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wan-Hsiang Hu

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung Memorial Hospital,Kaohsiung

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wan-Hsiang Hu, M.D.

Role: CONTACT

886-975056227

Facility Contacts

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Wan Hsiang Hu

Role: primary

+886-7-7317123 ext. 8008

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.

Reference Type BACKGROUND
PMID: 26786251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19451431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27417445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31500770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25163434 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24461239 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30312372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28041587 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30910865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30115829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31370717 (View on PubMed)

Other Identifiers

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202000035A3

Identifier Type: -

Identifier Source: org_study_id

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