Effect of Oral Protein Supplementation on Postoperative Complications in Elderly Sarcopenic Cancerous Patients

NCT04306562 | Terminated

• 1 other identifier: IRB632
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is a condition of reduced skeletal muscle associated with aging. It leads to poor outcome and increased risk of postoperative complications. Achieving protein and energy requirements is crucial point in sarcopenia treatment. In preoperative patients, daily consumption of protein should be at least 1.2-2.0 g of protein/kg/day or 25-35 g of protein in a meal to provide muscular protein synthesis. The objective of this study is to show that preoperative enteral protein supplementation in elderly cancerous patients, who are diagnosed with sarcopenia, can decrease morbidity such as postoperative complications; mortality and improve postoperative clinical outcomes after elective surgery.

Conditions

Sarcopenia; Cancer

Keywords

Protein supplementation; Perioperative

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  postoperative complications within 30 days after operation which will be recorded and classify into surgical or non-surgical complications. All complication will be graded using Dindo-Clavien classification into 5 grades; Grade I is any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions; Grade II is complication which requiring pharmacological treatment with drugs (other than such allowed for grade I), blood transfusions or total parenteral nutrition are also included; Grade III requires surgical, endoscopic or radiological intervention; Grade IV is life-threatening complication (including CNS complications) requiring ICU management; Grade V means death of a patient.

  30 days after operation

Secondary Outcomes (2)

• mortality rate

  90 days after operation

• duration of hospital admission

  through patients discharge, an average of 1 week

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients in an intervention group will be ask about a history of food consumption in the past seven days to analyze a nutritive value of food consumption with a program (INMUCAL-Nutrients V.4.0, Institute of Nutrition, Mahidol University) and estimate an enteral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day with nutritional counseling by researchers. Special enteral formula will be selected if patients have specific conditions including renal failure, hyperglycemia/diabetes and liver failure, acute and chronic pulmonary disease and immunocompromised states. Otherwise, standard formula will be provided. Duration of enteral protein supplementation is at least 14 days from a preanesthetic clinic visit to a day of surgery.

Dietary Supplement: enteral nutrition supplement

Control group

NO INTERVENTION

Patients in a control group will be sent to assess and improve nutritional status by primary doctor as a conventional care pathway.

Interventions

enteral nutrition supplement DIETARY_SUPPLEMENT

enteral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day for at least 14 days from a preanesthetic clinic visit to a day of surgery.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age of equal or more than 65 years.
• Diagnosed cancer of gastrointestinal tract, hepatopancreaticobiliary tract, urology, head and neck, ear-nose-throat or gynecological cancer.
• Scheduled for elective surgery with the duration more than 2 hours will be enrolled in this study.

You may not qualify if:

• Unable to walk, stand up, perform hand grip test, communicate and follow commands.
• Having factors affect bioimpedance (BIA) analysis such as pacemaker, alcohol drinking or heavy exercise within 12 hours prior to analysis or take medication, herb or hormone that affect muscle mass and strength such as estrogen, testosterone, thyroxine, steroid.
• Patients diagnosed with no sarcopenia or probable sarcopenia or have a contraindication for enteral nutrition will be excluded from this study.

Sponsors & Collaborators

• Siriraj Hospital: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

Related Publications (10)

• Fielding RA, Vellas B, Evans WJ, Bhasin S, Morley JE, Newman AB, Abellan van Kan G, Andrieu S, Bauer J, Breuille D, Cederholm T, Chandler J, De Meynard C, Donini L, Harris T, Kannt A, Keime Guibert F, Onder G, Papanicolaou D, Rolland Y, Rooks D, Sieber C, Souhami E, Verlaan S, Zamboni M. Sarcopenia: an undiagnosed condition in older adults. Current consensus definition: prevalence, etiology, and consequences. International working group on sarcopenia. J Am Med Dir Assoc. 2011 May;12(4):249-56. doi: 10.1016/j.jamda.2011.01.003. Epub 2011 Mar 4.

  PMID: 21527165 BACKGROUND

• 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 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

  PMID: 31081853 BACKGROUND

• Cruz-Jentoft AJ, Landi F, Topinkova E, Michel JP. Understanding sarcopenia as a geriatric syndrome. Curr Opin Clin Nutr Metab Care. 2010 Jan;13(1):1-7. doi: 10.1097/MCO.0b013e328333c1c1.

  PMID: 19915458 BACKGROUND

• 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: 24461239 BACKGROUND

• Simonsen C, de Heer P, Bjerre ED, Suetta C, Hojman P, Pedersen BK, Svendsen LB, Christensen JF. Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis. Ann Surg. 2018 Jul;268(1):58-69. doi: 10.1097/SLA.0000000000002679.

  PMID: 29373365 BACKGROUND

• Reisinger KW, van Vugt JL, Tegels JJ, Snijders C, Hulsewe KW, Hoofwijk AG, Stoot JH, Von Meyenfeldt MF, Beets GL, Derikx JP, Poeze M. Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery. Ann Surg. 2015 Feb;261(2):345-52. doi: 10.1097/SLA.0000000000000628.

  PMID: 24651133 BACKGROUND

• Kuwada K, Kuroda S, Kikuchi S, Yoshida R, Nishizaki M, Kagawa S, Fujiwara T. Sarcopenia and Comorbidity in Gastric Cancer Surgery as a Useful Combined Factor to Predict Eventual Death from Other Causes. Ann Surg Oncol. 2018 May;25(5):1160-1166. doi: 10.1245/s10434-018-6354-4. Epub 2018 Feb 5.

  PMID: 29404820 BACKGROUND

• Friedman J, Lussiez A, Sullivan J, Wang S, Englesbe M. Implications of sarcopenia in major surgery. Nutr Clin Pract. 2015 Apr;30(2):175-9. doi: 10.1177/0884533615569888. Epub 2015 Feb 13.

  PMID: 25681482 BACKGROUND

• Ma BW, Chen XY, Fan SD, Zhang FM, Huang DD, Li B, Shen X, Zhuang CL, Yu Z. Impact of sarcopenia on clinical outcomes after radical gastrectomy for patients without nutritional risk. Nutrition. 2019 May;61:61-66. doi: 10.1016/j.nut.2018.10.025. Epub 2018 Oct 24.

  PMID: 30703570 BACKGROUND

• Lieffers JR, Bathe OF, Fassbender K, Winget M, Baracos VE. Sarcopenia is associated with postoperative infection and delayed recovery from colorectal cancer resection surgery. Br J Cancer. 2012 Sep 4;107(6):931-6. doi: 10.1038/bjc.2012.350. Epub 2012 Aug 7.

  PMID: 22871883 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Mingkwan Wongyingsinn

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The allocation sequence will be concealed from the researcher enrolling and assessing participants in sequentially numbered, opaque, sealed and stapled envelopes. Corresponding envelopes will be opened only after the enrolled participants completed all baseline assessments and it was time to allocate the intervention. Whereas patients and physicians allocated to the intervention group are aware of the allocated arm, outcome assessors and data analysts will be kept blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Patients who were diagnosed with sarcopenia or severe sarcopenia, will be randomly assigned following stratified randomization procedures (computerized random numbers) to one of two groups.

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 13, 2020
• Study Start: October 1, 2019
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)