NCT05867810

Brief Summary

Cross-sectional study. Data on clinical, anthropometric, biochemical profile and dietary intake Upper Gastrointestinal Cancer Patients upon admission are traced and collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
409

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

May 10, 2023

Last Update Submit

May 18, 2023

Conditions

Keywords

Upper Gastrointestinal Cancer Patientsupon admissionNutritional Status

Outcome Measures

Primary Outcomes (4)

  • nutrition assessment

    anthropometry (weight)

    within 2 hours upon admission

  • nutrition assessment

    dietary assessment

    within 24 hours upon admission

  • nutrition assessment

    nutrition impact symptom (NIS)

    within 24 hours upon admission

  • nutrition assessment

    subjective global assessment (SGA)

    within 24 hours upon admission

Secondary Outcomes (2)

  • Biochemical data

    within 2 hours upon admission

  • Biochemical data

    within 2 hours upon admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

histologically confirmed Upper Gastrointestinal Cancers

You may qualify if:

  • Admitted UGIC patient
  • Seen by dietitian in ward

You may not qualify if:

  • Not admitted in ward
  • Aged \<18 years old
  • Non-Malaysian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Kanser Negara (National Cancer Institute)

Putrajaya, 62250, Malaysia

Location

Related Publications (9)

  • Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.

    PMID: 29369092BACKGROUND
  • Reber E, Schonenberger KA, Vasiloglou MF, Stanga Z. Nutritional Risk Screening in Cancer Patients: The First Step Toward Better Clinical Outcome. Front Nutr. 2021 Apr 7;8:603936. doi: 10.3389/fnut.2021.603936. eCollection 2021.

    PMID: 33898493BACKGROUND
  • Ho CY, Ibrahim Z, Abu Zaid Z, Mat Daud Z', Md Yusop NB. Clinical malnutrition predictive model among gynecologic cancer patients prior to elective operation: A cross-sectional study. Clin Nutr. 2021 Jun;40(6):4373-4379. doi: 10.1016/j.clnu.2021.01.008. Epub 2021 Jan 12.

    PMID: 33485706BACKGROUND
  • Detsky AS, McLaughlin JR, Baker JP, Johnston N, Whittaker S, Mendelson RA, Jeejeebhoy KN. What is subjective global assessment of nutritional status? JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):8-13. doi: 10.1177/014860718701100108.

    PMID: 3820522BACKGROUND
  • Chen MJ, Wu IC, Chen YJ, Wang TE, Chang YF, Yang CL, Huang WC, Chang WK, Sheu BS, Wu MS, Lin JT, Chu CH. Nutrition therapy in esophageal cancer-Consensus statement of the Gastroenterological Society of Taiwan. Dis Esophagus. 2018 Aug 1;31(8). doi: 10.1093/dote/doy016.

    PMID: 29860406BACKGROUND
  • Allum W, Lordick F, Alsina M, Andritsch E, Ba-Ssalamah A, Beishon M, Braga M, Caballero C, Carneiro F, Cassinello F, Dekker JW, Delgado-Bolton R, Haustermans K, Henning G, Hutter B, Lovey J, Netikova IS, Obermannova R, Oberst S, Rostoft S, Saarto T, Seufferlein T, Sheth S, Wynter-Blyth V, Costa A, Naredi P. ECCO essential requirements for quality cancer care: Oesophageal and gastric cancer. Crit Rev Oncol Hematol. 2018 Feb;122:179-193. doi: 10.1016/j.critrevonc.2017.12.019. Epub 2018 Jan 2.

    PMID: 29458786BACKGROUND
  • Deftereos I, Hitch D, Butzkueven S, Carter V, Arslan J, Fetterplace K, Fox K, Ottaway A, Pierce K, Steer B, Varghese J, Kiss N, Yeung J. Implementation of a standardised perioperative nutrition care pathway in upper gastrointestinal cancer surgery: A multisite pilot study. J Hum Nutr Diet. 2023 Apr;36(2):479-492. doi: 10.1111/jhn.13018. Epub 2022 May 18.

    PMID: 35441757BACKGROUND
  • Azizah A, Hashimah B, Siti Zubaidah A, Puteri N, Nabihah A, Sukumaran R, et al. Malaysian National Cancer Registry Report (MNCR) 2012-2016. 2019.

    BACKGROUND
  • Deftereos I, Yeung JMC, Arslan J, Carter VM, Isenring E, Kiss N, On Behalf Of The Nourish Point Prevalence Study Group. Assessment of Nutritional Status and Nutrition Impact Symptoms in Patients Undergoing Resection for Upper Gastrointestinal Cancer: Results from the Multi-Centre NOURISH Point Prevalence Study. Nutrients. 2021 Sep 24;13(10):3349. doi: 10.3390/nu13103349.

    PMID: 34684353BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dietitian

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 22, 2023

Study Start

October 1, 2020

Primary Completion

May 31, 2022

Study Completion

March 31, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations