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Upper Gastrointestinal Cancer Patients Upon AdmissionRSCH ID-22-012NCT05867810

Nutritional Status Among Upper Gastrointestinal Cancer Patients Upon Admission

An observational study of Upper Gastrointestinal Cancer Patients Upon Admission and Nutritional Status, run by Universiti Putra Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
How many people
409 participants
Where
1 siteMalaysia
Study dates
1 Oct 2020to 31 Mar 2023
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: histologically confirmed Upper Gastrointestinal Cancers

Who may be able to join

  • Admitted UGIC patient
  • Seen by dietitian in ward

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Institut Kanser Negara (National Cancer Institute)

    Putrajaya, 62250

Other trials in Malaysia

About this study

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

Read the detailed description

As per routine care, on the day of admission, nutrition assessment and clinical examination of all in-patients will be carried out. Patient screening will be done by assigned investigator based on the dietitian censes based on inclusion and exclusion criteria. The investigator will trace the data from medical system and record in the data collection form.

Keywords
Upper Gastrointestinal Cancer Patients, upon admission, Nutritional Status

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. nutrition assessment

    anthropometry (weight)

    Measured: within 2 hours upon admission

  2. nutrition assessment

    dietary assessment

    Measured: within 24 hours upon admission

  3. nutrition assessment

    nutrition impact symptom (NIS)

    Measured: within 24 hours upon admission

  4. nutrition assessment

    subjective global assessment (SGA)

    Measured: within 24 hours upon admission

Secondary outcomes (2)

  1. Biochemical data

    albumin

    Measured: within 2 hours upon admission

  2. Biochemical data

    lymphocytes

    Measured: within 2 hours upon admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start1 Oct 2020
  3. Primary completion31 May 2022
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
409 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05867810
Sponsor's protocol ID
NMRR ID-22-00792-HKU
Other IDs
RSCH ID-22-01272-6KC
Acronym
RSCH ID-22-012
Status last verified
May 2023
First submitted
10 May 2023
Last updated
22 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29369092

  • 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.

    PubMed 33898493

  • 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.

    PubMed 33485706

  • 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.

    PubMed 3820522

  • 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.

    PubMed 29860406

  • 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.

    PubMed 29458786

  • 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.

    PubMed 35441757

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

  • 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.

    PubMed 34684353

Questions about this trial

What is this clinical trial studying?

An observational study of Upper Gastrointestinal Cancer Patients Upon Admission and Nutritional Status, run by Universiti Putra Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

nutrition assessment (time frame: within 2 hours upon admission). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05867810, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.

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