Nutritional Status Among Upper Gastrointestinal Cancer Patients Upon Admission

Nutritional Status Clinical Trial

— RSCH ID-22-012  

Official title:

Nutritional Status Among Upper Gastrointestinal Cancer Patients Upon Admission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05867810
• Other study ID #: NMRR ID-22-00792-HKU
• Secondary ID: RSCH ID-22-01272
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: March 31, 2023
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admitted UGIC patient
• Seen by dietitian in ward

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Gastrointestinal Neoplasms
• Nutritional Status

Locations

Country	Name	City	State
Malaysia	Institut Kanser Negara (National Cancer Institute)	Putrajaya

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	National Cancer Institute, Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (9)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Anesth Analg. 2018 Nov;127(5):e95. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nutrition assessment	anthropometry (weight)	within 2 hours upon admission
Primary	nutrition assessment	dietary assessment	within 24 hours upon admission
Primary	nutrition assessment	nutrition impact symptom (NIS)	within 24 hours upon admission
Primary	nutrition assessment	subjective global assessment (SGA)	within 24 hours upon admission
Secondary	Biochemical data	albumin	within 2 hours upon admission
Secondary	Biochemical data	lymphocytes	within 2 hours upon admission