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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Sarcopenia, Cancer

Intervention / Treatment
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* Dietary Supplement: enteral nutrition supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Control group<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protein supplementation, Perioperative