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

March 28, 2024 updated by: Mingkwan Wongyingsinn, MD, Siriraj Hospital

Effect of Oral Protein Supplementation on Postoperative Complications in Elderly Sarcopenic Cancerous Patients: A Randomized Controlled Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Sarcopenia is a condition of reduced skeletal muscle mass associated with aging process leading to decrease muscle strength and function. International Working Group on Sarcopenia defines Sarcopenia as an age-associated loss of skeletal muscle mass and function, and the European Working Group on Sarcopenia in Older People (EWGSOP) defines sarcopenia as a syndrome characterized by progressive and generalized loss of skeletal muscle mass and strength with a risk of adverse outcomes such as physical disability, poor quality of life, and death. The prevalence of sarcopenia is higher in population older than 65 years and leading to poor outcomes such as mobility disorders, disability, poor quality of life and death. Sarcopenia is also associated with an increased risk of postoperative complications such as overgrowth of bacteria in the gastrointestinal tract, postoperative infections, sepsis, delayed wound healing prolonged inpatient rehabilitation, mortality and consequently a longer length of hospital stay, even without nutritional risk.

Sarcopenia contains multifactorial etiology, such as age-related, inadequate energy and/or protein intake, sedentary activity such as bed rest, and coexisting disease such as organ failure, inflammatory disease or endocrine disease. One important goal of developing treatment strategies in sarcopenic patients is to achieve protein and energy requirements. 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. Perioperative oral protein supplements have been demonstrated to increase serum albumin and total protein, improve postoperative functional walking capacity and decrease postoperative infection in elderly or critically ill patients. However, there have been no studies on the benefit of preoperative protein supplement in cancerous patients.

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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
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.
No Intervention: Control group
Patients in a control group will be sent to assess and improve nutritional status by primary doctor as a conventional care pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 30 days after operation
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality rate
Time Frame: 90 days after operation
number of patient death within 90 days after operation of elective surgery
90 days after operation
duration of hospital admission
Time Frame: through patients discharge, an average of 1 week
duration of hospital admission record in days.
through patients discharge, an average of 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Principal Investigator: Mingkwan Wongyingsinn, Faculty of Medicine Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

March 28, 2024

Study Completion (Actual)

March 28, 2024

Study Registration Dates

First Submitted

March 9, 2020

First Submitted That Met QC Criteria

March 11, 2020

First Posted (Actual)

March 13, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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