NCT04567459

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 27, 2021

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

26 days

First QC Date

August 26, 2020

Last Update Submit

January 26, 2021

Conditions

Colorectal Cancer

Keywords

colorectal cancerChemotherapyNutritionSarcopenia

Outcome Measures

Primary Outcomes (13)

  • 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).

Study Arms (2)

control group: chemotherapy

NO INTERVENTION

No intervention

experimental group: chemotherapy and nutrition support

EXPERIMENTAL

Premium amino acids 1pc bid for 6 months

Dietary Supplement: Premium Amino Acids

Interventions

Premium Amino AcidsDIETARY_SUPPLEMENT

after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening

experimental group: chemotherapy and nutrition support

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital,Kaohsiung

Kaohsiung City, 833, Taiwan

RECRUITING

Related Publications (11)

  • 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.

    PMID: 26786251BACKGROUND

  • 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.

    PMID: 19451431BACKGROUND

  • 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.

    PMID: 27417445BACKGROUND

  • 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.

    PMID: 31500770BACKGROUND

  • 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.

    PMID: 25163434BACKGROUND

  • 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.

    PMID: 24461239BACKGROUND

  • 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.

    PMID: 30312372BACKGROUND

  • 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.

    PMID: 28041587BACKGROUND

  • 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.

    PMID: 30910865BACKGROUND

  • 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.

    PMID: 30115829BACKGROUND

  • 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.

    PMID: 31370717BACKGROUND

MeSH Terms

Conditions

Colorectal NeoplasmsSarcopenia

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Wan-Hsiang Hu, M.D.

CONTACT

886-975056227gary.hu0805@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 28, 2020

Study Start

January 27, 2021

Primary Completion

February 22, 2021

Study Completion

February 22, 2021

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

TW(1)